Experience

Infinity Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• QMS Manager

  • Aug 2021 - Present

  Implement eLMS and eDMS systems in a pharmaceutical startup of 30+ employees and participate in the development of the Quality Management system. ACHIEVEMENTS HIGHLIGHTS Contract Review and Negotiation. Initiate, review, and negotiate Quality Agreements, Master Service Agreements, and Statements of Work with vendors in support of implementation, validation, and auditing services of eLMS and eDMS systems implementation, including Project Management across each implementation while… Show more Implement eLMS and eDMS systems in a pharmaceutical startup of 30+ employees and participate in the development of the Quality Management system. ACHIEVEMENTS HIGHLIGHTS Contract Review and Negotiation. Initiate, review, and negotiate Quality Agreements, Master Service Agreements, and Statements of Work with vendors in support of implementation, validation, and auditing services of eLMS and eDMS systems implementation, including Project Management across each implementation while developing appropriate documentation and training to support each system roll-out. Provide leadership and expertise on all aspects of Quality Management System to confirm items identified during gap assessment have been properly addressed and the QMS and product adheres to regulatory compliance to ensure that products are successfully introduced and maintained domestically and globally pursuant to U.S. FDA, Health Canada, EU, and other regulations. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Show less Implement eLMS and eDMS systems in a pharmaceutical startup of 30+ employees and participate in the development of the Quality Management system. ACHIEVEMENTS HIGHLIGHTS Contract Review and Negotiation. Initiate, review, and negotiate Quality Agreements, Master Service Agreements, and Statements of Work with vendors in support of implementation, validation, and auditing services of eLMS and eDMS systems implementation, including Project Management across each implementation while… Show more Implement eLMS and eDMS systems in a pharmaceutical startup of 30+ employees and participate in the development of the Quality Management system. ACHIEVEMENTS HIGHLIGHTS Contract Review and Negotiation. Initiate, review, and negotiate Quality Agreements, Master Service Agreements, and Statements of Work with vendors in support of implementation, validation, and auditing services of eLMS and eDMS systems implementation, including Project Management across each implementation while developing appropriate documentation and training to support each system roll-out. Provide leadership and expertise on all aspects of Quality Management System to confirm items identified during gap assessment have been properly addressed and the QMS and product adheres to regulatory compliance to ensure that products are successfully introduced and maintained domestically and globally pursuant to U.S. FDA, Health Canada, EU, and other regulations. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Show less



ANIKA THERAPEUTICS S.R.L.

• Italy
• Research Services
• 1 - 100 Employee

• Documentation and Training Manager

  • Feb 2021 - Aug 2021

  Master Control Administrator: Set up new accounts for employees within the system and for both the Documentation and Training modules. Trouble shoot any issues that End-Users may have. Develop new workflows as required. Attend Master Control workshops to remain fluent with new developments. Review updates as they are released by Master Control and work with the Validation group to document validation requirements due to updates. Document Control and Records Management: Initiated new… Show more Master Control Administrator: Set up new accounts for employees within the system and for both the Documentation and Training modules. Trouble shoot any issues that End-Users may have. Develop new workflows as required. Attend Master Control workshops to remain fluent with new developments. Review updates as they are released by Master Control and work with the Validation group to document validation requirements due to updates. Document Control and Records Management: Initiated new Statement of Work and Purchase Order with approved off-site Vendor to initiate process of removing records older than 5 years of age to vendor site for scanning and providing a secured electronic library where end-users would be able to access the records at any time. Provided training to all new employees on the use of the electronic library, as well as usage of Master Control and Training Modules. I managed one Document Control Specialist to assist in the department duties which consisted of: issuance of batch records and filing of records that remained on site. Developed new workflows for Technical Reports and Protocols within Master Control where IDs could be issued within Master Control, the Protocols and Reports could be developed, reviewed, and approved electronically and were then secured within Master Control electronically, rather than issuing paper copies for archive. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training Work with Area Managers to ensure appropriate training requirements are identified for each department and that training is completed and documented on time. This include GxP training, New Hire Training and annual training requirements for all employees sitewide. Show less Master Control Administrator: Set up new accounts for employees within the system and for both the Documentation and Training modules. Trouble shoot any issues that End-Users may have. Develop new workflows as required. Attend Master Control workshops to remain fluent with new developments. Review updates as they are released by Master Control and work with the Validation group to document validation requirements due to updates. Document Control and Records Management: Initiated new… Show more Master Control Administrator: Set up new accounts for employees within the system and for both the Documentation and Training modules. Trouble shoot any issues that End-Users may have. Develop new workflows as required. Attend Master Control workshops to remain fluent with new developments. Review updates as they are released by Master Control and work with the Validation group to document validation requirements due to updates. Document Control and Records Management: Initiated new Statement of Work and Purchase Order with approved off-site Vendor to initiate process of removing records older than 5 years of age to vendor site for scanning and providing a secured electronic library where end-users would be able to access the records at any time. Provided training to all new employees on the use of the electronic library, as well as usage of Master Control and Training Modules. I managed one Document Control Specialist to assist in the department duties which consisted of: issuance of batch records and filing of records that remained on site. Developed new workflows for Technical Reports and Protocols within Master Control where IDs could be issued within Master Control, the Protocols and Reports could be developed, reviewed, and approved electronically and were then secured within Master Control electronically, rather than issuing paper copies for archive. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training Work with Area Managers to ensure appropriate training requirements are identified for each department and that training is completed and documented on time. This include GxP training, New Hire Training and annual training requirements for all employees sitewide. Show less



Jabil Healthcare

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• QA Document Control Supervisor

  • Nov 2018 - Aug 2021

  QA DOCUMENT CONTROL SUPERVISOR JABIL HEALTHCARE – CLINTON, MA November 2018- August 2021 Manage day to day Document Control activities, including Change Control, for the Clinton and Devens sites in support of Jabil Quality Management Systems requirements. ACHIEVEMENTS HIGHLIGHTS Document Control: Manage and maintain Document Management Systems within Lotus Notes and NWQS. Responsible for Change Control activities by reviewing, advising, and approving Change Control requests… Show more QA DOCUMENT CONTROL SUPERVISOR JABIL HEALTHCARE – CLINTON, MA November 2018- August 2021 Manage day to day Document Control activities, including Change Control, for the Clinton and Devens sites in support of Jabil Quality Management Systems requirements. ACHIEVEMENTS HIGHLIGHTS Document Control: Manage and maintain Document Management Systems within Lotus Notes and NWQS. Responsible for Change Control activities by reviewing, advising, and approving Change Control requests within the system Provide support to Document Control team (3 Specialist and 1 Technical Writer in Clinton and 2 Specialists in Devens). Support internal and external audits by managing backroom activities. Maintain all document control activities to FDA Quality Systems Regulation requirements Records Management: Responsible for the records management, including off-site storage for both the Clinton and Devens sites. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Manage Training system processes and system within NWQS. Work with Area Managers to ensure appropriate training requirements are identified for each department and that training is completed and documented on time. Provide backup training support for new hire training. Show less QA DOCUMENT CONTROL SUPERVISOR JABIL HEALTHCARE – CLINTON, MA November 2018- August 2021 Manage day to day Document Control activities, including Change Control, for the Clinton and Devens sites in support of Jabil Quality Management Systems requirements. ACHIEVEMENTS HIGHLIGHTS Document Control: Manage and maintain Document Management Systems within Lotus Notes and NWQS. Responsible for Change Control activities by reviewing, advising, and approving Change Control requests… Show more QA DOCUMENT CONTROL SUPERVISOR JABIL HEALTHCARE – CLINTON, MA November 2018- August 2021 Manage day to day Document Control activities, including Change Control, for the Clinton and Devens sites in support of Jabil Quality Management Systems requirements. ACHIEVEMENTS HIGHLIGHTS Document Control: Manage and maintain Document Management Systems within Lotus Notes and NWQS. Responsible for Change Control activities by reviewing, advising, and approving Change Control requests within the system Provide support to Document Control team (3 Specialist and 1 Technical Writer in Clinton and 2 Specialists in Devens). Support internal and external audits by managing backroom activities. Maintain all document control activities to FDA Quality Systems Regulation requirements Records Management: Responsible for the records management, including off-site storage for both the Clinton and Devens sites. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Manage Training system processes and system within NWQS. Work with Area Managers to ensure appropriate training requirements are identified for each department and that training is completed and documented on time. Provide backup training support for new hire training. Show less



Foundation Medicine

• United States
• Biotechnology Research
• 700 & Above Employee

• QA Document Control Manager

  • Apr 2017 - Nov 2018

  QA DOCUMENTATION MANAGER FOUNDATION MEDICINE – CAMBRIDGE, MA April 2017- November 2018 Manage day to day Document Control activities, to support FMI Lab Operations and IVD Development. ACHIEVEMENTS HIGHLIGHTS Document Control: Implementation of Master Control eDMS system within company defined timelines. Development of system documentation. Developed training program for system rollout and successfully performed training for Cambridge, North Carolina, and German sites prior to… Show more QA DOCUMENTATION MANAGER FOUNDATION MEDICINE – CAMBRIDGE, MA April 2017- November 2018 Manage day to day Document Control activities, to support FMI Lab Operations and IVD Development. ACHIEVEMENTS HIGHLIGHTS Document Control: Implementation of Master Control eDMS system within company defined timelines. Development of system documentation. Developed training program for system rollout and successfully performed training for Cambridge, North Carolina, and German sites prior to Go-Live and following Go-Live. Responsible for new hire training each week of eDMS and Document Control activities, including OJT and departmental training requirements. Records Management: Developed Records Management program for the Cambridge site, including initiating the review and approval of the SOW with an approved vendor for off-site storage of records. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Manage Training system processes and system within a company designed training system. Work with Area Managers to ensure appropriate training requirements are identified for each department and that training is completed and documented on time. Show less QA DOCUMENTATION MANAGER FOUNDATION MEDICINE – CAMBRIDGE, MA April 2017- November 2018 Manage day to day Document Control activities, to support FMI Lab Operations and IVD Development. ACHIEVEMENTS HIGHLIGHTS Document Control: Implementation of Master Control eDMS system within company defined timelines. Development of system documentation. Developed training program for system rollout and successfully performed training for Cambridge, North Carolina, and German sites prior to… Show more QA DOCUMENTATION MANAGER FOUNDATION MEDICINE – CAMBRIDGE, MA April 2017- November 2018 Manage day to day Document Control activities, to support FMI Lab Operations and IVD Development. ACHIEVEMENTS HIGHLIGHTS Document Control: Implementation of Master Control eDMS system within company defined timelines. Development of system documentation. Developed training program for system rollout and successfully performed training for Cambridge, North Carolina, and German sites prior to Go-Live and following Go-Live. Responsible for new hire training each week of eDMS and Document Control activities, including OJT and departmental training requirements. Records Management: Developed Records Management program for the Cambridge site, including initiating the review and approval of the SOW with an approved vendor for off-site storage of records. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Manage Training system processes and system within a company designed training system. Work with Area Managers to ensure appropriate training requirements are identified for each department and that training is completed and documented on time. Show less



Siemens Healthcare Diagnostics

• Walpole, Massachusetts, United States

• Documentation Manager

  • Mar 2013 - Apr 2017

  DOCUMENTATION MANAGER SIEMENS HEALTHCARE DIAGNOSTICS (NOW SIEMENS HEALTHINEERS) – WALPOLE, MA March 2013 – April 2017 Managed a team of 5 Documentation Specialists, 1 Records Specialist, 2 ERP Specialists, and 2 Label Specialists to maintain the SAP and Documentum system within Document Control for documents, Bills of Materials and Labeling requirements at the Walpole facility. ACHIEVEMENTS HIGHLIGHTS Document Control, ERP and Labeling: Managed the team to ensure compliance to… Show more DOCUMENTATION MANAGER SIEMENS HEALTHCARE DIAGNOSTICS (NOW SIEMENS HEALTHINEERS) – WALPOLE, MA March 2013 – April 2017 Managed a team of 5 Documentation Specialists, 1 Records Specialist, 2 ERP Specialists, and 2 Label Specialists to maintain the SAP and Documentum system within Document Control for documents, Bills of Materials and Labeling requirements at the Walpole facility. ACHIEVEMENTS HIGHLIGHTS Document Control, ERP and Labeling: Managed the team to ensure compliance to company and regulatory requirements when performing activities in Document Control, BOM management or Label management. Worked as part of the Corporate Initiative to transfer QMS documentation from SAP to Documentum for quality management purposes. Oversaw label management within Lotus Notes. Provide leadership and expertise Provided guidance and oversight on methods, procedures and standardization and requirements of all controlled processes. Oversaw the change process to ensure only approved and validated changes were incorporated into released documentation. Supported internal and external audit activities and responded to CAPA activities directed to Document Control or Records. Ensure biennial review was performed on time and tracked for Management Review, as well as performed metrics for Document Lifecycle and Review Lifecycles. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Ensure department personal were adequately trained on processes related to document control activities and provided training to end-users on SAP and Documentum. Show less DOCUMENTATION MANAGER SIEMENS HEALTHCARE DIAGNOSTICS (NOW SIEMENS HEALTHINEERS) – WALPOLE, MA March 2013 – April 2017 Managed a team of 5 Documentation Specialists, 1 Records Specialist, 2 ERP Specialists, and 2 Label Specialists to maintain the SAP and Documentum system within Document Control for documents, Bills of Materials and Labeling requirements at the Walpole facility. ACHIEVEMENTS HIGHLIGHTS Document Control, ERP and Labeling: Managed the team to ensure compliance to… Show more DOCUMENTATION MANAGER SIEMENS HEALTHCARE DIAGNOSTICS (NOW SIEMENS HEALTHINEERS) – WALPOLE, MA March 2013 – April 2017 Managed a team of 5 Documentation Specialists, 1 Records Specialist, 2 ERP Specialists, and 2 Label Specialists to maintain the SAP and Documentum system within Document Control for documents, Bills of Materials and Labeling requirements at the Walpole facility. ACHIEVEMENTS HIGHLIGHTS Document Control, ERP and Labeling: Managed the team to ensure compliance to company and regulatory requirements when performing activities in Document Control, BOM management or Label management. Worked as part of the Corporate Initiative to transfer QMS documentation from SAP to Documentum for quality management purposes. Oversaw label management within Lotus Notes. Provide leadership and expertise Provided guidance and oversight on methods, procedures and standardization and requirements of all controlled processes. Oversaw the change process to ensure only approved and validated changes were incorporated into released documentation. Supported internal and external audit activities and responded to CAPA activities directed to Document Control or Records. Ensure biennial review was performed on time and tracked for Management Review, as well as performed metrics for Document Lifecycle and Review Lifecycles. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Ensure department personal were adequately trained on processes related to document control activities and provided training to end-users on SAP and Documentum. Show less



Micell Technologies, Inc.

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Assurance Specialist

  • Oct 2009 - Feb 2016

  QUALITY ASSURANCE SPECIALIST MICELL TECHNOLOGIES – DURHAM, NC October 2009 – February 2016 Assisted in the development of the QMS for a combination medical device product which brought about a successful ISO 13485 certification for the company ACHIEVEMENTS HIGHLIGHTS Document Control: Developed QMS Standard Operating Procedures needed for the company such as Document Control, Biennial Review, Training, Good Documentation Practices, Internal and External Audits, and many more.… Show more QUALITY ASSURANCE SPECIALIST MICELL TECHNOLOGIES – DURHAM, NC October 2009 – February 2016 Assisted in the development of the QMS for a combination medical device product which brought about a successful ISO 13485 certification for the company ACHIEVEMENTS HIGHLIGHTS Document Control: Developed QMS Standard Operating Procedures needed for the company such as Document Control, Biennial Review, Training, Good Documentation Practices, Internal and External Audits, and many more. Managed the document control and training process and set up filing system for both. Assisted the Clinical group in maintaining their files and SOPs. Provide leadership and expertise Provided guidance and oversight on methods, procedures and standardization and requirements of all controlled processes. Oversaw the change process to ensure only approved and validated changes were incorporated into released documentation. Supported internal and external audit activities and responded to CAPA activities directed to Document Control, training, or records. Participated in Management Review meetings and helped to develop metrics for the document control and training processes. I also assisted in vendor audits. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Ensure department personal were adequately trained on processes related to document control activities and provided training to end-users on ISO 13485 and relevant regulatory requirements Show less QUALITY ASSURANCE SPECIALIST MICELL TECHNOLOGIES – DURHAM, NC October 2009 – February 2016 Assisted in the development of the QMS for a combination medical device product which brought about a successful ISO 13485 certification for the company ACHIEVEMENTS HIGHLIGHTS Document Control: Developed QMS Standard Operating Procedures needed for the company such as Document Control, Biennial Review, Training, Good Documentation Practices, Internal and External Audits, and many more.… Show more QUALITY ASSURANCE SPECIALIST MICELL TECHNOLOGIES – DURHAM, NC October 2009 – February 2016 Assisted in the development of the QMS for a combination medical device product which brought about a successful ISO 13485 certification for the company ACHIEVEMENTS HIGHLIGHTS Document Control: Developed QMS Standard Operating Procedures needed for the company such as Document Control, Biennial Review, Training, Good Documentation Practices, Internal and External Audits, and many more. Managed the document control and training process and set up filing system for both. Assisted the Clinical group in maintaining their files and SOPs. Provide leadership and expertise Provided guidance and oversight on methods, procedures and standardization and requirements of all controlled processes. Oversaw the change process to ensure only approved and validated changes were incorporated into released documentation. Supported internal and external audit activities and responded to CAPA activities directed to Document Control, training, or records. Participated in Management Review meetings and helped to develop metrics for the document control and training processes. I also assisted in vendor audits. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Ensure department personal were adequately trained on processes related to document control activities and provided training to end-users on ISO 13485 and relevant regulatory requirements Show less



AVEDRO

• Belgium
• Farming

• QA Manager

  • Aug 2008 - Sep 2009

  QA MANAGER AVEDRO – WALTHAM, MA August 2008 – September 2009 Established, coordinated, and implemented the document control processes including editing and maintaining controlled documentation; processing change requests; interacting with contract manufacturers, and maintaining Device History Records within a GMP facility. ACHIEVEMENTS HIGHLIGHTS Document Control and Implementation: Managed the implementation of the quality management systems and ensured compliance to US and… Show more QA MANAGER AVEDRO – WALTHAM, MA August 2008 – September 2009 Established, coordinated, and implemented the document control processes including editing and maintaining controlled documentation; processing change requests; interacting with contract manufacturers, and maintaining Device History Records within a GMP facility. ACHIEVEMENTS HIGHLIGHTS Document Control and Implementation: Managed the implementation of the quality management systems and ensured compliance to US and European regulations, standards, and the Quality Manual. Managed the implementation and management of most aspects of the quality systems including document and data control, management responsibility (including management review), quality planning, training, vendor approval and monitoring, equipment calibration, complaint handling and trending, product recalls/advisory notices, CAPA system, internal audit system, non-conforming material and incoming inspection Implemented Arena PLM for Document and Change Control, Supplier Management and Design Control activities. Provide leadership and expertise Responsible for promoting awareness of, and training to, regulatory and compliance requirements throughout the organization. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Ensure department personal were adequately trained on processes related to document control activities, Arena PLM, and appropriate FDA cGMPs. Show less QA MANAGER AVEDRO – WALTHAM, MA August 2008 – September 2009 Established, coordinated, and implemented the document control processes including editing and maintaining controlled documentation; processing change requests; interacting with contract manufacturers, and maintaining Device History Records within a GMP facility. ACHIEVEMENTS HIGHLIGHTS Document Control and Implementation: Managed the implementation of the quality management systems and ensured compliance to US and… Show more QA MANAGER AVEDRO – WALTHAM, MA August 2008 – September 2009 Established, coordinated, and implemented the document control processes including editing and maintaining controlled documentation; processing change requests; interacting with contract manufacturers, and maintaining Device History Records within a GMP facility. ACHIEVEMENTS HIGHLIGHTS Document Control and Implementation: Managed the implementation of the quality management systems and ensured compliance to US and European regulations, standards, and the Quality Manual. Managed the implementation and management of most aspects of the quality systems including document and data control, management responsibility (including management review), quality planning, training, vendor approval and monitoring, equipment calibration, complaint handling and trending, product recalls/advisory notices, CAPA system, internal audit system, non-conforming material and incoming inspection Implemented Arena PLM for Document and Change Control, Supplier Management and Design Control activities. Provide leadership and expertise Responsible for promoting awareness of, and training to, regulatory and compliance requirements throughout the organization. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Ensure department personal were adequately trained on processes related to document control activities, Arena PLM, and appropriate FDA cGMPs. Show less



ImmunoGen, Inc.

• United States
• Biotechnology Research
• 200 - 300 Employee

• Documentation Manager

  • Mar 2005 - Aug 2008

  QA DOCUMENTATION MANAGER IMMUNOGEN – NORWOOD, MA March 2005 – August 2008 Managed a team of 4 Documentation Specialist and, 1 Records Specialist, and was responsible for backroom management during internal and external (customer) audits. ACHIEVEMENTS HIGHLIGHTS Document Control: Project team lead and SME for implementation of QUMAS DocCompliance, an eDMS system which incorporated trending matrices for the issuance, review, approval, and training of system documentation.… Show more QA DOCUMENTATION MANAGER IMMUNOGEN – NORWOOD, MA March 2005 – August 2008 Managed a team of 4 Documentation Specialist and, 1 Records Specialist, and was responsible for backroom management during internal and external (customer) audits. ACHIEVEMENTS HIGHLIGHTS Document Control: Project team lead and SME for implementation of QUMAS DocCompliance, an eDMS system which incorporated trending matrices for the issuance, review, approval, and training of system documentation. Participated in the development, review, and implementation of the Application Configuration Specification (ACS) for DocCompliance and Process Compliance Modules. I also participated in the development of the URS and FRS system documents. Working with our in-house IT department, I participated in the development and execution of the IQ/OQ/PQ documentation. Provide leadership and expertise Provided guidance and oversight on methods, procedures and standardization and requirements of all controlled processes. Developed Standard Operating Procedures and Work Instructions and rolled out training for use of DocCompliance for all End-Users prior to Go-Live. Oversaw the change process to ensure only approved and validated changes were incorporated into released documentation. Supported internal and external audit activities and responded to CAPA activities directed to Document Control or Records. Ensure biennial review was performed on time and tracked for Management Review, as well as performed metrics for Document Lifecycle and Review Lifecycles. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Ensure department personal were adequately trained on processes related to document control activities and provided training to end-users on DocCompliance and Record Retention activities. Show less QA DOCUMENTATION MANAGER IMMUNOGEN – NORWOOD, MA March 2005 – August 2008 Managed a team of 4 Documentation Specialist and, 1 Records Specialist, and was responsible for backroom management during internal and external (customer) audits. ACHIEVEMENTS HIGHLIGHTS Document Control: Project team lead and SME for implementation of QUMAS DocCompliance, an eDMS system which incorporated trending matrices for the issuance, review, approval, and training of system documentation.… Show more QA DOCUMENTATION MANAGER IMMUNOGEN – NORWOOD, MA March 2005 – August 2008 Managed a team of 4 Documentation Specialist and, 1 Records Specialist, and was responsible for backroom management during internal and external (customer) audits. ACHIEVEMENTS HIGHLIGHTS Document Control: Project team lead and SME for implementation of QUMAS DocCompliance, an eDMS system which incorporated trending matrices for the issuance, review, approval, and training of system documentation. Participated in the development, review, and implementation of the Application Configuration Specification (ACS) for DocCompliance and Process Compliance Modules. I also participated in the development of the URS and FRS system documents. Working with our in-house IT department, I participated in the development and execution of the IQ/OQ/PQ documentation. Provide leadership and expertise Provided guidance and oversight on methods, procedures and standardization and requirements of all controlled processes. Developed Standard Operating Procedures and Work Instructions and rolled out training for use of DocCompliance for all End-Users prior to Go-Live. Oversaw the change process to ensure only approved and validated changes were incorporated into released documentation. Supported internal and external audit activities and responded to CAPA activities directed to Document Control or Records. Ensure biennial review was performed on time and tracked for Management Review, as well as performed metrics for Document Lifecycle and Review Lifecycles. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Ensure department personal were adequately trained on processes related to document control activities and provided training to end-users on DocCompliance and Record Retention activities. Show less



Celldex Therapeutics

• United States
• Biotechnology Research
• 100 - 200 Employee

• Documentation and Training Manager

  • Jan 2004 - Mar 2005

  DOCUMENTATION AND TRAINING MANAGER CELLDEX THERAPEUTICS – NEEDHAM, MA January 2004 – March 2005 Managed a team of 1 Documentation Specialist and participated in the validation of a new GMP compliant manufacturing facility in Fall River. ACHIEVEMENTS HIGHLIGHTS Document Control and Training: Managed and developed documentation in dual facilities, including Record Retention activities. Developed comprehensive training program for compliance to GxP guidelines, regulatory… Show more DOCUMENTATION AND TRAINING MANAGER CELLDEX THERAPEUTICS – NEEDHAM, MA January 2004 – March 2005 Managed a team of 1 Documentation Specialist and participated in the validation of a new GMP compliant manufacturing facility in Fall River. ACHIEVEMENTS HIGHLIGHTS Document Control and Training: Managed and developed documentation in dual facilities, including Record Retention activities. Developed comprehensive training program for compliance to GxP guidelines, regulatory requirements and quality system requirements and developed a records management program for off-site storage and retrieval of quality, regulatory and clinical documentation. Provide leadership and expertise Provided guidance and oversight on methods, procedures and standardization and requirements of all controlled processes. Supported internal and external audit activities and responded to CAPA activities directed to Document Control or Records. Ensure biennial review was performed on time and tracked for Management Review, as well as performed metrics for Document Lifecycle and Review Lifecycles. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Ensure department personal were adequately trained on processes related to document control activities and record retention activities. Show less DOCUMENTATION AND TRAINING MANAGER CELLDEX THERAPEUTICS – NEEDHAM, MA January 2004 – March 2005 Managed a team of 1 Documentation Specialist and participated in the validation of a new GMP compliant manufacturing facility in Fall River. ACHIEVEMENTS HIGHLIGHTS Document Control and Training: Managed and developed documentation in dual facilities, including Record Retention activities. Developed comprehensive training program for compliance to GxP guidelines, regulatory… Show more DOCUMENTATION AND TRAINING MANAGER CELLDEX THERAPEUTICS – NEEDHAM, MA January 2004 – March 2005 Managed a team of 1 Documentation Specialist and participated in the validation of a new GMP compliant manufacturing facility in Fall River. ACHIEVEMENTS HIGHLIGHTS Document Control and Training: Managed and developed documentation in dual facilities, including Record Retention activities. Developed comprehensive training program for compliance to GxP guidelines, regulatory requirements and quality system requirements and developed a records management program for off-site storage and retrieval of quality, regulatory and clinical documentation. Provide leadership and expertise Provided guidance and oversight on methods, procedures and standardization and requirements of all controlled processes. Supported internal and external audit activities and responded to CAPA activities directed to Document Control or Records. Ensure biennial review was performed on time and tracked for Management Review, as well as performed metrics for Document Lifecycle and Review Lifecycles. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Ensure department personal were adequately trained on processes related to document control activities and record retention activities. Show less



Etex Corporation

• United States
• Biotechnology
• 1 - 100 Employee

• Documentation and Regulatory Compliance Manager

  • Feb 2001 - Jan 2004

  DOCUMENTATION AND REGULATORY COMPLIANCE MANAGER ETEX. CORP.- CAMBRIDGE, MA February 2001 – January 2004 Responsible for the development and management of quality documentation in a small startup company developing a novel bioresorbable bone substitute material. ACHIEVEMENTS HIGHLIGHTS Document Control and Batch Record Issuance/Release: Responsible for documentation development, issuance and tracking of batch records and lot number assignment. Performance of in-process and final… Show more DOCUMENTATION AND REGULATORY COMPLIANCE MANAGER ETEX. CORP.- CAMBRIDGE, MA February 2001 – January 2004 Responsible for the development and management of quality documentation in a small startup company developing a novel bioresorbable bone substitute material. ACHIEVEMENTS HIGHLIGHTS Document Control and Batch Record Issuance/Release: Responsible for documentation development, issuance and tracking of batch records and lot number assignment. Performance of in-process and final batch record release. Issued labeling to manufacturing for in-process and final product. Provide leadership and expertise Provided guidance and oversight on methods, procedures and standardization and requirements of all controlled processes. Oversaw the change process to ensure only approved and validated changes were incorporated into released documentation. Supported internal and external audit activities and responded to CAPA activities directed to Document Control or Records. Ensure biennial review was performed on time and tracked for Management Review, as well as performed metrics for Document Lifecycle and Review Lifecycles. Liaison with partners in the creation, review, approval and final release of Instruction-for-Use documents and system SOPs. Performed internal and supplier qualification audits and was the Quality liaison for third party and partner audits. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Ensure company personal were adequately trained on processes related to system and process activities and provided training to end-users on GxP requirements. Show less DOCUMENTATION AND REGULATORY COMPLIANCE MANAGER ETEX. CORP.- CAMBRIDGE, MA February 2001 – January 2004 Responsible for the development and management of quality documentation in a small startup company developing a novel bioresorbable bone substitute material. ACHIEVEMENTS HIGHLIGHTS Document Control and Batch Record Issuance/Release: Responsible for documentation development, issuance and tracking of batch records and lot number assignment. Performance of in-process and final… Show more DOCUMENTATION AND REGULATORY COMPLIANCE MANAGER ETEX. CORP.- CAMBRIDGE, MA February 2001 – January 2004 Responsible for the development and management of quality documentation in a small startup company developing a novel bioresorbable bone substitute material. ACHIEVEMENTS HIGHLIGHTS Document Control and Batch Record Issuance/Release: Responsible for documentation development, issuance and tracking of batch records and lot number assignment. Performance of in-process and final batch record release. Issued labeling to manufacturing for in-process and final product. Provide leadership and expertise Provided guidance and oversight on methods, procedures and standardization and requirements of all controlled processes. Oversaw the change process to ensure only approved and validated changes were incorporated into released documentation. Supported internal and external audit activities and responded to CAPA activities directed to Document Control or Records. Ensure biennial review was performed on time and tracked for Management Review, as well as performed metrics for Document Lifecycle and Review Lifecycles. Liaison with partners in the creation, review, approval and final release of Instruction-for-Use documents and system SOPs. Performed internal and supplier qualification audits and was the Quality liaison for third party and partner audits. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Ensure company personal were adequately trained on processes related to system and process activities and provided training to end-users on GxP requirements. Show less



DePuy Mitek Holding Corp

• Documentation and Records Supervisor

  • Aug 1999 - Feb 2001

  DOCUMENTATIONTATION SUPERVISOR AND RECORDS MANAGER DFEPUY MITEK (A JOHNSON AND JOHNSON COMPANY) – NORWOOD, MA August 1999 – February 2001 Managed and developed department staff of seven to provide system of review, approval and distribution of quality and regulatory documentation including engineering drawings, package labeling and product inserts. ACHIEVEMENTS HIGHLIGHTS Document Control: Implemented records management program. Created and implemented companywide records… Show more DOCUMENTATIONTATION SUPERVISOR AND RECORDS MANAGER DFEPUY MITEK (A JOHNSON AND JOHNSON COMPANY) – NORWOOD, MA August 1999 – February 2001 Managed and developed department staff of seven to provide system of review, approval and distribution of quality and regulatory documentation including engineering drawings, package labeling and product inserts. ACHIEVEMENTS HIGHLIGHTS Document Control: Implemented records management program. Created and implemented companywide records management program to satisfy GMP requirements for record retention. Provide leadership and expertise Provided guidance and oversight on methods, procedures and standardization and requirements of all controlled processes. Oversaw the change process to ensure only approved and validated changes were incorporated into released documentation. Supported internal and external audit activities and responded to CAPA activities directed to Document Control, labeling or Records. Ensure biennial review was performed on time and tracked for Management Review, as well as performed metrics for Document Lifecycle and Review Lifecycles. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Ensure department personal were adequately trained on processes related to document control activities. Show less DOCUMENTATIONTATION SUPERVISOR AND RECORDS MANAGER DFEPUY MITEK (A JOHNSON AND JOHNSON COMPANY) – NORWOOD, MA August 1999 – February 2001 Managed and developed department staff of seven to provide system of review, approval and distribution of quality and regulatory documentation including engineering drawings, package labeling and product inserts. ACHIEVEMENTS HIGHLIGHTS Document Control: Implemented records management program. Created and implemented companywide records… Show more DOCUMENTATIONTATION SUPERVISOR AND RECORDS MANAGER DFEPUY MITEK (A JOHNSON AND JOHNSON COMPANY) – NORWOOD, MA August 1999 – February 2001 Managed and developed department staff of seven to provide system of review, approval and distribution of quality and regulatory documentation including engineering drawings, package labeling and product inserts. ACHIEVEMENTS HIGHLIGHTS Document Control: Implemented records management program. Created and implemented companywide records management program to satisfy GMP requirements for record retention. Provide leadership and expertise Provided guidance and oversight on methods, procedures and standardization and requirements of all controlled processes. Oversaw the change process to ensure only approved and validated changes were incorporated into released documentation. Supported internal and external audit activities and responded to CAPA activities directed to Document Control, labeling or Records. Ensure biennial review was performed on time and tracked for Management Review, as well as performed metrics for Document Lifecycle and Review Lifecycles. Good Manufacturing Practices. Advised on and provided guidance to FDA cGMPs for relevant products. Training: Ensure department personal were adequately trained on processes related to document control activities. Show less



DEPUY ORTHOPAEDICS, INC.

• Raynham, Massachusetts, United States

• Document Control Coordinator

  • Mar 1997 - Aug 1999

  DOCUMENT CONTROL COORDINATOR DFEPUY ORTHOPEDICS (A JOHNSON AND JOHNSON COMPANY) – RAYNHAM, MA March 1997 – August 1999 Participated in company project and worked with various departments throughout company to develop a more efficient documentation system resulting in reduced documentation lifecycles by 15%. ACHIEVEMENTS HIGHLIGHTS Document Control: Responsible for maintaining document management system and on-line retrieval system (EPR) across multiple sites. Developed and… Show more DOCUMENT CONTROL COORDINATOR DFEPUY ORTHOPEDICS (A JOHNSON AND JOHNSON COMPANY) – RAYNHAM, MA March 1997 – August 1999 Participated in company project and worked with various departments throughout company to develop a more efficient documentation system resulting in reduced documentation lifecycles by 15%. ACHIEVEMENTS HIGHLIGHTS Document Control: Responsible for maintaining document management system and on-line retrieval system (EPR) across multiple sites. Developed and performed training for end-users for EPR. Good Manufacturing Practices. Worked within the guidelines of GMP and ensured documentation was following GMP guidelines. Training: Ensured all training was current prior to executing any work. Show less DOCUMENT CONTROL COORDINATOR DFEPUY ORTHOPEDICS (A JOHNSON AND JOHNSON COMPANY) – RAYNHAM, MA March 1997 – August 1999 Participated in company project and worked with various departments throughout company to develop a more efficient documentation system resulting in reduced documentation lifecycles by 15%. ACHIEVEMENTS HIGHLIGHTS Document Control: Responsible for maintaining document management system and on-line retrieval system (EPR) across multiple sites. Developed and… Show more DOCUMENT CONTROL COORDINATOR DFEPUY ORTHOPEDICS (A JOHNSON AND JOHNSON COMPANY) – RAYNHAM, MA March 1997 – August 1999 Participated in company project and worked with various departments throughout company to develop a more efficient documentation system resulting in reduced documentation lifecycles by 15%. ACHIEVEMENTS HIGHLIGHTS Document Control: Responsible for maintaining document management system and on-line retrieval system (EPR) across multiple sites. Developed and performed training for end-users for EPR. Good Manufacturing Practices. Worked within the guidelines of GMP and ensured documentation was following GMP guidelines. Training: Ensured all training was current prior to executing any work. Show less