Experience

Immunomedics

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Quality Assurance Specialist

  • Jan 2019 - Present



Tris Pharma

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• QA Compliance Specialist

  • May 2016 - Jan 2019



MTF Biologics

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

• Manager Inventory Control

  • Aug 2014 - Feb 2016



International Technidyne Corporation

• Sr. Supervisor Quality Records

  • Mar 2011 - Aug 2014

  Oversees all facets of Records Management including the company’s documentation system and procedures. Ensures department staff completes compliant reviews, audits and archiving of Manufacturing and Quality records associated with the release of finished goods. Responsibilities: •Ensure the completeness, accuracy, legibility, traceability and retrieval of records. •Responsible for improvement of staffs performance, procedures and processes. •Ensure department staff adheres to all Standard Operating Procedures (SOPs). •Analyze data/metrics; provide reports as needed. Utilized error tracking spreadsheet for TAT and provided metrics for departmental meetings. ● Implemented good practice of cGMP’s and ensured training on revised documents was documented and completed in a timely manner. •Assist with internal and external audits. •Directly supported archival of documents for proper storage and integration for preparation of department shutdown. ● Participated effectively in cross-functional work teams to solve problems, improve processes involving the Instrument Repair committee to ensure instruments moved through the system in a timely manner. Accomplishments: •Implementation and approval of change control documents. •Proceduralized processing of Engineering Change Orders. •Revised Good Documentation SOP and performed site wide training on new process. •Implemented Shop Floor/Auditing Program •Increased TAT of records and reduced errors that were in final review through implementation of online record review. •Re-evaluated error tracking system. •Reduced the cost of scanning process for interdepartmental batch records. Show less



Laureate Pharma

• Biotechnology Research
• 1 - 100 Employee

• Compliance Specialist

  • 2010 - 2011

  Perform internal audits as well as review of manufacturing records and validation reports. * Perform internal audits of all areas including Manufacturing, Laboratory (Micro/QC), Facility, Documentation. All reports were communicated directly to the CEO of the company as well as other management personnel. * Reviewed Upstream, Downstream and filling records for external clients. Communicated findings to clients during meetings. Perform internal audits as well as review of manufacturing records and validation reports. * Perform internal audits of all areas including Manufacturing, Laboratory (Micro/QC), Facility, Documentation. All reports were communicated directly to the CEO of the company as well as other management personnel. * Reviewed Upstream, Downstream and filling records for external clients. Communicated findings to clients during meetings.



Hoffmann LaRoche

• Compliance Specialist

  • Mar 2002 - Jul 2010

  * Author, review, approve and provide training on SOP's to associates and clients. *Works independently and in conjunction with production personnel to ensure current Good Manufacturing Practices and regulatory compliance of marketed and non-marketed products. * Audit Shop Floor activities by reviewing cGMP manufacturing related documentation to identify compliance deficiencies and potential improvements. Maintained readiness for EU and US inspections/certification for isolation gowning. * Issued Compliance Review Reports for cGMP deficiencies. * Participated effectively in cross-functional work teams to solve problems, improve or re-engineer processes. Works with clients to determine standards of quality and promote those standards in work groups. Employs effective teamwork and negotiating skills to set timelines and priorities that result in achieving goals, support client projects and meet client needs in the most effective manner without sacrificing quality. Quasar Team - Warehouse project to streamline process of incoming/outgoing materials. FMEA Team - Remove cardboard box usage in the manufacturing process. Variance Trend and Tracking Team - Evaluated compression equipment to reduce variances. Incoming Material Team - Reduced the number of damaged drums received in warehouse. * Perform finished product identity testing for applicable marketed products. * Maintained open and effective lines of communication that all personnel are adequately informed in matters pertinent to their work and interests. * Classroom training for Green Belt and Six Sigma.; Show less



Kos Pharmaceuticals

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Auditor

  • 2001 - 2002

  Performed daily internal audits of manufacturing/warehouse area. Review and approve executed Manufacturing records and contract Packaging records. ● Review and update SOP’s. ● Trained production personnel in cGMP’s. ● Support Safety Team through bi-weekly meetings. ● Issuance of Variance (CAPA), provide documents for FDA inspections. Performed daily internal audits of manufacturing/warehouse area. Review and approve executed Manufacturing records and contract Packaging records. ● Review and update SOP’s. ● Trained production personnel in cGMP’s. ● Support Safety Team through bi-weekly meetings. ● Issuance of Variance (CAPA), provide documents for FDA inspections.



AAI Pharmaceuticals

• QA Documentation Specialist II

  • Jan 1999 - Jan 2001

  Preparation of client reports, presentations and documentation needed for internal audits for prospective clients. * Responsible for stability area for client studies. Received products in and handled setup of studies. * Perform internal audits of facility for readiness of customer inspections. Preparation of client reports, presentations and documentation needed for internal audits for prospective clients. * Responsible for stability area for client studies. Received products in and handled setup of studies. * Perform internal audits of facility for readiness of customer inspections.



Data Scope Corporation

• Quality Systems Specialist

  • Jan 1998 - Jan 1999

  Document/process all product complaints received worldwide from all users, and determine if reportable as per FDA Medical Device Reporting (MDR) and European Vigilance Reporting (EVR) requirements. Assisted in performing internal audits. Provided compliance support for current and new products. * Provide support to quality systems by preparing product complaint/MDR summary reports for biannual management review. * Training of all field personnel on issuing product complaints. Document/process all product complaints received worldwide from all users, and determine if reportable as per FDA Medical Device Reporting (MDR) and European Vigilance Reporting (EVR) requirements. Assisted in performing internal audits. Provided compliance support for current and new products. * Provide support to quality systems by preparing product complaint/MDR summary reports for biannual management review. * Training of all field personnel on issuing product complaints.



Ciba Geigy/Novartis Pharmaceuticals

• Technical Investigator

  • Jan 1996 - Jan 1998

  Prepare technical reports and documents as well as perform internal audits in the manufacturing and packaging areas. * Review and evaluate operations, data and procedures for cGMP compliance. Document deviations (CAPA). * Process all product complaints and address FDA concerns regarding complaint investigations. Prepare technical reports and documents as well as perform internal audits in the manufacturing and packaging areas. * Review and evaluate operations, data and procedures for cGMP compliance. Document deviations (CAPA). * Process all product complaints and address FDA concerns regarding complaint investigations.



Ciba Geigy

• Supervisor Solid Oral Dosage

  • Jan 1993 - Jan 1996

  Coordinate production support activities with production, QC, DRA, engineering and production support groups. Supervised operators in the solid oral dosage department as well as Liquid and Transdermal area. * Provide technical support experience for all equipment involved in cleaning validation. * Increased production in Liquid Ointment department and decreased labor costs by minimizing weekend overtime. * Implemented good practice of cGMP safety training and updating of SOP's. * Involved in Continuous Improvement Team to help track investigation reports once reports were initiated by the author. Show less



Cia Geigy

• Validation Engineer

  • Jan 1990 - Jan 1993

  Conduct the evaluation and validation programs for the manufacture of validation batches (sampling/testing for cleaning validation). * Author and execute protocol for study. Conduct the evaluation and validation programs for the manufacture of validation batches (sampling/testing for cleaning validation). * Author and execute protocol for study.