Lisa AnnMarie Fleshman, MS
Executive Director, Quality and Compliance at Sanguine Biosciences at Sanguine- Claim this Profile
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Topline Score
Bio
Karley Zinsmeister
When I think of AnnMarie the first word that comes to mind is methodical. AnnMarie has very in depth knowledge about the company SOPs and regulatory guidelines which she is constantly making sure the labs are updated on changes. She is one of the most organized and hardest working people that I have ever met. I work closely with AnnMarie in regards to a QA/lab relationship. She always checks in to make sure our schedules line up and quickly corrects any errors that are found. Even on her busiest days, she somehow makes time for the lab and answers any questions that arise. AnnMarie wants to help everyone around her succeed and I would highly recommend her.
Naiche Adler
AnnMarie (Lisa) has been a pleasure to work with. She is very knowledgable regarding regulatory compliance, highly attentive, and detail-oriented. She has a comprehensive understanding of FDA regulations and our company SOPs and the reasoning behind them. She has been excellent at guiding me as I transition from less-regulated academic research to the highly-regulated environment of commercial preclinical testing. She is a hard and focused worker with great loyalty, and I highly recommend her.
Karley Zinsmeister
When I think of AnnMarie the first word that comes to mind is methodical. AnnMarie has very in depth knowledge about the company SOPs and regulatory guidelines which she is constantly making sure the labs are updated on changes. She is one of the most organized and hardest working people that I have ever met. I work closely with AnnMarie in regards to a QA/lab relationship. She always checks in to make sure our schedules line up and quickly corrects any errors that are found. Even on her busiest days, she somehow makes time for the lab and answers any questions that arise. AnnMarie wants to help everyone around her succeed and I would highly recommend her.
Naiche Adler
AnnMarie (Lisa) has been a pleasure to work with. She is very knowledgable regarding regulatory compliance, highly attentive, and detail-oriented. She has a comprehensive understanding of FDA regulations and our company SOPs and the reasoning behind them. She has been excellent at guiding me as I transition from less-regulated academic research to the highly-regulated environment of commercial preclinical testing. She is a hard and focused worker with great loyalty, and I highly recommend her.
Karley Zinsmeister
When I think of AnnMarie the first word that comes to mind is methodical. AnnMarie has very in depth knowledge about the company SOPs and regulatory guidelines which she is constantly making sure the labs are updated on changes. She is one of the most organized and hardest working people that I have ever met. I work closely with AnnMarie in regards to a QA/lab relationship. She always checks in to make sure our schedules line up and quickly corrects any errors that are found. Even on her busiest days, she somehow makes time for the lab and answers any questions that arise. AnnMarie wants to help everyone around her succeed and I would highly recommend her.
Naiche Adler
AnnMarie (Lisa) has been a pleasure to work with. She is very knowledgable regarding regulatory compliance, highly attentive, and detail-oriented. She has a comprehensive understanding of FDA regulations and our company SOPs and the reasoning behind them. She has been excellent at guiding me as I transition from less-regulated academic research to the highly-regulated environment of commercial preclinical testing. She is a hard and focused worker with great loyalty, and I highly recommend her.
Karley Zinsmeister
When I think of AnnMarie the first word that comes to mind is methodical. AnnMarie has very in depth knowledge about the company SOPs and regulatory guidelines which she is constantly making sure the labs are updated on changes. She is one of the most organized and hardest working people that I have ever met. I work closely with AnnMarie in regards to a QA/lab relationship. She always checks in to make sure our schedules line up and quickly corrects any errors that are found. Even on her busiest days, she somehow makes time for the lab and answers any questions that arise. AnnMarie wants to help everyone around her succeed and I would highly recommend her.
Naiche Adler
AnnMarie (Lisa) has been a pleasure to work with. She is very knowledgable regarding regulatory compliance, highly attentive, and detail-oriented. She has a comprehensive understanding of FDA regulations and our company SOPs and the reasoning behind them. She has been excellent at guiding me as I transition from less-regulated academic research to the highly-regulated environment of commercial preclinical testing. She is a hard and focused worker with great loyalty, and I highly recommend her.
Credentials
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ZenQMS Certified Administrator
ZenQMSAug, 2022- Sep, 2024 -
Researchers (IPS)
CITI Program, A Division of BRANYMay, 2021- Sep, 2024 -
Inspection Team Leader Training
College of American Pathologists (CAP)Feb, 2021- Sep, 2024 -
ICH Good Clinical Practice E6 (R2)
The Global Health NetworkJan, 2021- Sep, 2024 -
Supervisor Professional Certification
SkillPathNov, 2019- Sep, 2024 -
FDA's cGLP for Nonclinical Laboratory Studies
CALISOMay, 2014- Sep, 2024 -
Conflicts of Interest
CITI ProgramJun, 2021- Sep, 2024 -
Biomedical Responsible Conduct of Research
CITI ProgramJun, 2021- Sep, 2024 -
GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
CITI ProgramJun, 2021- Sep, 2024 -
Biomedical Researchers
CITI Program, A Division of BRANYMay, 2021- Sep, 2024 -
Good Laboratory Practice (GLP)
CITI Program, A Division of BRANYMay, 2020- Sep, 2024 -
GDPR and Human Subjects Research in the U.S.
CITI ProgramJun, 2021- Sep, 2024
Experience
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Sanguine
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Tobacco Manufacturing
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Executive Director, Quality and Compliance at Sanguine Biosciences
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Sep 2023 - Present
● Utilize a risk-based strategy to prioritize Quality Compliance Office operations for quality assurance and compliance activities ● The leader will have responsibility for developing, directing, implementing and maintaining standardization, optimization and/or continuous improvement of quality systems. ● Leading efforts that will ensure Compliance Excellence and Audit readiness assessing compliance gaps relative to client and regulatory requirements, and proposing solutions for… Show more ● Utilize a risk-based strategy to prioritize Quality Compliance Office operations for quality assurance and compliance activities ● The leader will have responsibility for developing, directing, implementing and maintaining standardization, optimization and/or continuous improvement of quality systems. ● Leading efforts that will ensure Compliance Excellence and Audit readiness assessing compliance gaps relative to client and regulatory requirements, and proposing solutions for improvement across the organization. ● Collecting and analyzing performance metrics across the enterprise to identify trends, risks and risk mitigations ● Provide overall GxP Quality Assurance (QA) leadership and strategic development for GxP Quality Assurance activities, to ensure collaborative team involvement and implementation of quality and compliance activities. ● Manage and develop Quality Assurance personnel, including recruitment, performance management, hiring, training and development. ● Best practices with documentation practices and compliance including leading SOP development activities and updates ● Expertise in implementing compliance and quality procedures associated with CFR Part 11, 45, 46, and 50. ● Experience with HIPAA compliance, documentation and implementation procedures ● The guiding principle of this role is to ensure a high level compliance of our global quality systems, and to support the drug development processes for our pharmaceutical and academic clients. ● Knows and understands Quality compliance processes and regulations, e.g. GCP regulations ● A thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation associated with disposition and product market compliance. ● Host and manage regulatory agency inspections and licensing business partner audits.
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Director, Quality and Compliance
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Feb 2022 - Sep 2023
● Lead SOP development activities and updates under the guidance of the Executive Leadership ● Oversee the Quality Input process and vendor management ● Best practices with documentation practices and compliance ● Expertise in implementing compliance and quality procedures associated with CFR Part 11, 45, 46, and 50. ● Experience with HIPAA compliance, documentation and implementation procedures ● Utilize a risk-based strategy to prioritize Quality Compliance Office operations… Show more ● Lead SOP development activities and updates under the guidance of the Executive Leadership ● Oversee the Quality Input process and vendor management ● Best practices with documentation practices and compliance ● Expertise in implementing compliance and quality procedures associated with CFR Part 11, 45, 46, and 50. ● Experience with HIPAA compliance, documentation and implementation procedures ● Utilize a risk-based strategy to prioritize Quality Compliance Office operations for quality assurance and compliance activities ● Business administration of computerized Quality Management Systems, with emphasis on document control and training systems ● Ensure QMS workflows progress in a timely fashion; compile and report QMS metrics to senior management ● Train system users and provide user support ● Review and approve QMS documentation including controlled documents, training material, deviations, laboratory investigations, CAPAs and change controls ● Identify and drive QMS continuous improvement efforts, including implementation of new computerized systems. ● Provide QA oversight of computer system and process validation efforts ● Review and approve validation documentation including master validation plans, specifications/requirements, protocols and test scripts, and summary reports ● Perform GCP/GxP audits of internal departments, external contract service providers, and computer systems
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Associate Director, GCP & GxP Quality Assurance and Compliance
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Apr 2021 - Feb 2022
-Leads the activity of the quality assurance department and staff, developing, implementing, and maintaining a system of quality and reliability for the organizations' products and development processes. -Utilizes a risk-based strategy to prioritize Quality Compliance Office operations for quality assurance and compliance activities, oversee the CAPA process, vendor management, and lead SOP development activities and updates for the company. -Enables proactive decision making and… Show more -Leads the activity of the quality assurance department and staff, developing, implementing, and maintaining a system of quality and reliability for the organizations' products and development processes. -Utilizes a risk-based strategy to prioritize Quality Compliance Office operations for quality assurance and compliance activities, oversee the CAPA process, vendor management, and lead SOP development activities and updates for the company. -Enables proactive decision making and supports the development and execution of effective and comprehensive action plans to address quality and compliance risks. -Plays an instrumental role in the administration of computerized Quality Management Systems (QMS) including document control, training, deviations, CAPAs, change controls, complaints, recalls, audits, and quality agreements. -Responsible for QA oversight of validation activities. -Lead SOP development activities and updates for the company -Oversee the CAPA process and vendor management -Exercises expertise in implementing compliance and quality procedures associated with CFR Parts 11, 45, 46, 50, and 58. -Ensures appropriate administration of computerized Quality Management Systems, with emphasis on document control and training systems -Reviews and approves QMS documentation including controlled documents, training material, deviations, laboratory investigations, CAPAs and change controls -Ensures QMS is compliant with health authority regulations. -Identifies and drives QMS continuous improvement efforts, including implementation of new computerized systems. -Provides QA oversight of computer system and process validation efforts -Reviews and approves validation documentation -Performs GCP/GxP audits of internal departments, external contract service providers, and computer systems
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Independent Consultant
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United States
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Technology, Information and Internet
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1 - 100 Employee
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GLP/GCP Quality Consultant
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Jan 2020 - Present
-Consultant providing advice on all aspects of pre-clinical GLP and clinical laboratory (GCP/GCLP) compliance -Work with internal and external customers to improve processes by providing technical guidance to quality teams, identify key work to be performed, build cross-functional and collaborative project teams, initiate action, lead efforts and achieve deadlines -Auditing services including inspection of facilities, suppliers and CROs, inspection of studies and review of data and… Show more -Consultant providing advice on all aspects of pre-clinical GLP and clinical laboratory (GCP/GCLP) compliance -Work with internal and external customers to improve processes by providing technical guidance to quality teams, identify key work to be performed, build cross-functional and collaborative project teams, initiate action, lead efforts and achieve deadlines -Auditing services including inspection of facilities, suppliers and CROs, inspection of studies and review of data and reports -Maintain and apply knowledge of current policies, regulations, and industrial processes -Perform GAP analysis or audits of customer facilities or suppliers -Provide GLP/GCP/GCLP training and preparation for regulatory inspections -Document QC and proofreading Show less -Consultant providing advice on all aspects of pre-clinical GLP and clinical laboratory (GCP/GCLP) compliance -Work with internal and external customers to improve processes by providing technical guidance to quality teams, identify key work to be performed, build cross-functional and collaborative project teams, initiate action, lead efforts and achieve deadlines -Auditing services including inspection of facilities, suppliers and CROs, inspection of studies and review of data and… Show more -Consultant providing advice on all aspects of pre-clinical GLP and clinical laboratory (GCP/GCLP) compliance -Work with internal and external customers to improve processes by providing technical guidance to quality teams, identify key work to be performed, build cross-functional and collaborative project teams, initiate action, lead efforts and achieve deadlines -Auditing services including inspection of facilities, suppliers and CROs, inspection of studies and review of data and reports -Maintain and apply knowledge of current policies, regulations, and industrial processes -Perform GAP analysis or audits of customer facilities or suppliers -Provide GLP/GCP/GCLP training and preparation for regulatory inspections -Document QC and proofreading Show less
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Precision For Medicine
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United States
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Biotechnology Research
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700 & Above Employee
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Quality Assurance Manager – Life Sciences
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Jan 2020 - Jan 2021
-Collaborate with operational and quality staff to plan and ensure harmonization of global processes and procedures. -Plan and direct resources and activities of the quality and compliance functions. Develop and maintain GxP audit programs for operations. -Lead inspection readiness activities. -Host external regulatory agency and notified body assessments and inspections (FDA, ISO9001, ISO13485, CAP). -Manage the Quality System and support the quality functions of all critical… Show more -Collaborate with operational and quality staff to plan and ensure harmonization of global processes and procedures. -Plan and direct resources and activities of the quality and compliance functions. Develop and maintain GxP audit programs for operations. -Lead inspection readiness activities. -Host external regulatory agency and notified body assessments and inspections (FDA, ISO9001, ISO13485, CAP). -Manage the Quality System and support the quality functions of all critical operations. -Review and approve quality system activities. -Participate in cost reduction and improvement programs. -Serve as the site management representative, providing updates to the Director, QA regarding status of the quality system, compliance status and performance relating to quality. -Advise staff to help meet established schedules or resolve technical or operational problems. -Plan, promote and organize training activities related to operations, quality assurance, and compliance. -Estimate and administer budget schedules and performance standards. -Maintain an up-to-date knowledge in the techniques of quality and in the company products/services and process technologies. -Responsible for ensuring management reviews of the quality system are conducted. -Maintains up-to-date knowledge of regulations and applicable worldwide standards and requirements. -Coordinate annual training for Bloodborne Pathogens, Hazard Communication, and Ergonomics. -Maintain the biological and chemical waste management programs to ensure compliance to Local, State and DOT regulations. -Manage the review of computer systems, process and equipment validations and re-validation in accordance with established Company policy. Compete validation protocols and reports and ensure compliance with all relevant Quality Standards and regulatory requirements. -Work to develop supplier partnership opportunities and ensure supplier qualifications meet current Quality Standards and regulatory requirements. Show less -Collaborate with operational and quality staff to plan and ensure harmonization of global processes and procedures. -Plan and direct resources and activities of the quality and compliance functions. Develop and maintain GxP audit programs for operations. -Lead inspection readiness activities. -Host external regulatory agency and notified body assessments and inspections (FDA, ISO9001, ISO13485, CAP). -Manage the Quality System and support the quality functions of all critical… Show more -Collaborate with operational and quality staff to plan and ensure harmonization of global processes and procedures. -Plan and direct resources and activities of the quality and compliance functions. Develop and maintain GxP audit programs for operations. -Lead inspection readiness activities. -Host external regulatory agency and notified body assessments and inspections (FDA, ISO9001, ISO13485, CAP). -Manage the Quality System and support the quality functions of all critical operations. -Review and approve quality system activities. -Participate in cost reduction and improvement programs. -Serve as the site management representative, providing updates to the Director, QA regarding status of the quality system, compliance status and performance relating to quality. -Advise staff to help meet established schedules or resolve technical or operational problems. -Plan, promote and organize training activities related to operations, quality assurance, and compliance. -Estimate and administer budget schedules and performance standards. -Maintain an up-to-date knowledge in the techniques of quality and in the company products/services and process technologies. -Responsible for ensuring management reviews of the quality system are conducted. -Maintains up-to-date knowledge of regulations and applicable worldwide standards and requirements. -Coordinate annual training for Bloodborne Pathogens, Hazard Communication, and Ergonomics. -Maintain the biological and chemical waste management programs to ensure compliance to Local, State and DOT regulations. -Manage the review of computer systems, process and equipment validations and re-validation in accordance with established Company policy. Compete validation protocols and reports and ensure compliance with all relevant Quality Standards and regulatory requirements. -Work to develop supplier partnership opportunities and ensure supplier qualifications meet current Quality Standards and regulatory requirements. Show less
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MilliporeSigma
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United States
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Biotechnology Research
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700 & Above Employee
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Quality Assurance Specialist III (Sr.)
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Sep 2018 - Jan 2020
- Supports Director of Quality Assurance in maintaining day-to-day operations of the department. - Manages the fast-paced environment of toxicology with a high-volume workload, tight timelines and changing priorities. - Schedules workload for QA department and maintains QA schedule. - Allocates work and projects, monitors progress, timelines, and completion - Collaborates with department heads including senior leadership about quality and compliance issues as well as progress… Show more - Supports Director of Quality Assurance in maintaining day-to-day operations of the department. - Manages the fast-paced environment of toxicology with a high-volume workload, tight timelines and changing priorities. - Schedules workload for QA department and maintains QA schedule. - Allocates work and projects, monitors progress, timelines, and completion - Collaborates with department heads including senior leadership about quality and compliance issues as well as progress updates on improvement activities. - Leads full investigations of deviations, CAPAs, and effectiveness checks. - A site SME for full investigation root cause analysis events. - Provides GLP training to the toxicology division. - Participates in and leads departmental business, process, or general regulatory projects on cross-functional project teams. - Serves as liaison with operations to support consistent practice and advice. - Leads facility and regulatory audits (FDA, ISO17025, etc). - Provides training and guidance to QAU personnel and other departments. - Participates in or leads QRB meetings. - Assures the protocol requirements are met by auditing the protocol, raw data, data summary tables, draft and final reports associated with nonclinical studies to evaluate regulatory compliance. - Plans, conducts and reports study-specific laboratory inspections to assess compliance with GLP regulations/industry standards. - Assures QA departmental inspection reports and any other supporting documentation or required records are appropriately processed and archived, as appropriate. - Identifies regulatory compliance issues and provides regulatory support to departments. - Constructively interacts and communicates with employees in various settings. - Keeps QAU and QA Management apprised of compliance issues through frequent updates. - Audits multiple disciplines (genetic toxicology, mammalian toxicology, AHS). - Participates in various improvement teams and pilot programs.
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Quality Assurance Specialist II
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Apr 2017 - Sep 2018
- Assured protocol requirements were met by auditing the protocol, raw data, data summary tables, draft and final reports associated with non-clinical studies to evaluate regulatory compliance. - Planned, conducted, and reported study-specific laboratory inspections to assess compliance with GLP regulations/industry standards. - Assured QA departmental inspection reports and any other supporting documentation or required records were appropriately processed and archived, as… Show more - Assured protocol requirements were met by auditing the protocol, raw data, data summary tables, draft and final reports associated with non-clinical studies to evaluate regulatory compliance. - Planned, conducted, and reported study-specific laboratory inspections to assess compliance with GLP regulations/industry standards. - Assured QA departmental inspection reports and any other supporting documentation or required records were appropriately processed and archived, as appropriate. - Identified regulatory compliance issues and provided regulatory support to various departments. - Constructively interacted and communicated with employees in various settings. - Kept QAU and QA management apprised of compliance issues through frequent updates. - Co-hosted and hosted client visits and regulatory inspections. - Serves as a liason with operations deppartments to support consistent practice and advice. - Completes facility and subcontractor/vendor audits. - Provides training and guidance to QAU personnel. - Assist in the planning, development, and delivery of comprehensive GLP training programs as needed. - Audits with familiarity in FDA, EPA, and applicable international regulations.
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BioTelemetry, Inc.
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United States
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Biotechnology Research
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100 - 200 Employee
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Regulatory Compliance Analyst
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Sep 2016 - Feb 2017
- Responsible for the communication and documentation associated with Quality Systems and Quality Assurance as part of Regulatory Compliance requirements and governed by Quality System Procedures. - Monitored quality systems for all areas relating to Good Clinical Practice (GCP) and 21 CFR Part 11 compliance. - Monitored Quality System Procedure review and facilitated departmental authors to conduct document revisions. - Identified/lead process improvement and harmonization efforts… Show more - Responsible for the communication and documentation associated with Quality Systems and Quality Assurance as part of Regulatory Compliance requirements and governed by Quality System Procedures. - Monitored quality systems for all areas relating to Good Clinical Practice (GCP) and 21 CFR Part 11 compliance. - Monitored Quality System Procedure review and facilitated departmental authors to conduct document revisions. - Identified/lead process improvement and harmonization efforts that promote best practices. - Hosted client audits and FDA inspections. - Conducted internal GCP audits. - Initiated and reviewed SOPs. - Participated in internal facility, vendor, and supplemental inspections. - Delivered basic quality and regulatory training. - Ensured that systems used in QA were properly maintained and notified management of any service failures. - Monitored, logged, and evaluated internal/external Complaints and Deviations. - Monitored, logged, evaluated, and wrote CAPA reports. - Evaluated responses to inspection reports and performed follow-up with respondents, management, or others to ensure resolution. Show less - Responsible for the communication and documentation associated with Quality Systems and Quality Assurance as part of Regulatory Compliance requirements and governed by Quality System Procedures. - Monitored quality systems for all areas relating to Good Clinical Practice (GCP) and 21 CFR Part 11 compliance. - Monitored Quality System Procedure review and facilitated departmental authors to conduct document revisions. - Identified/lead process improvement and harmonization efforts… Show more - Responsible for the communication and documentation associated with Quality Systems and Quality Assurance as part of Regulatory Compliance requirements and governed by Quality System Procedures. - Monitored quality systems for all areas relating to Good Clinical Practice (GCP) and 21 CFR Part 11 compliance. - Monitored Quality System Procedure review and facilitated departmental authors to conduct document revisions. - Identified/lead process improvement and harmonization efforts that promote best practices. - Hosted client audits and FDA inspections. - Conducted internal GCP audits. - Initiated and reviewed SOPs. - Participated in internal facility, vendor, and supplemental inspections. - Delivered basic quality and regulatory training. - Ensured that systems used in QA were properly maintained and notified management of any service failures. - Monitored, logged, and evaluated internal/external Complaints and Deviations. - Monitored, logged, evaluated, and wrote CAPA reports. - Evaluated responses to inspection reports and performed follow-up with respondents, management, or others to ensure resolution. Show less
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Covance
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United States
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Research Services
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700 & Above Employee
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GLP/GCP QA Officer
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Feb 2015 - Sep 2016
- Performed protocol, data, report, and in-lab phase inspections to verify conformance to applicable SOP and regulatory requirements. - Evaluated responses to inspection reports and performed follow-up with respondents, management, or others to ensure resolution. - Ensured that systems used in QA are properly maintained and notified management of any service failures. - Managed all aspects of personal and team workload, daily micro-scheduling, as well as organization and… Show more - Performed protocol, data, report, and in-lab phase inspections to verify conformance to applicable SOP and regulatory requirements. - Evaluated responses to inspection reports and performed follow-up with respondents, management, or others to ensure resolution. - Ensured that systems used in QA are properly maintained and notified management of any service failures. - Managed all aspects of personal and team workload, daily micro-scheduling, as well as organization and prioritization related to a full workload. - Performed study sign-off including but not limited to QA statement preparation (internal/external) and report finalization. - Initiated and Reviewed SOPs and participated in internal facility, vendor, and supplemental inspections. - Delivered basic quality and regulatory training. - Identified/lead process improvement and harmonization efforts that promoted best practices. - Hosted/co-hosted client audits and FDA inspections. Show less - Performed protocol, data, report, and in-lab phase inspections to verify conformance to applicable SOP and regulatory requirements. - Evaluated responses to inspection reports and performed follow-up with respondents, management, or others to ensure resolution. - Ensured that systems used in QA are properly maintained and notified management of any service failures. - Managed all aspects of personal and team workload, daily micro-scheduling, as well as organization and… Show more - Performed protocol, data, report, and in-lab phase inspections to verify conformance to applicable SOP and regulatory requirements. - Evaluated responses to inspection reports and performed follow-up with respondents, management, or others to ensure resolution. - Ensured that systems used in QA are properly maintained and notified management of any service failures. - Managed all aspects of personal and team workload, daily micro-scheduling, as well as organization and prioritization related to a full workload. - Performed study sign-off including but not limited to QA statement preparation (internal/external) and report finalization. - Initiated and Reviewed SOPs and participated in internal facility, vendor, and supplemental inspections. - Delivered basic quality and regulatory training. - Identified/lead process improvement and harmonization efforts that promoted best practices. - Hosted/co-hosted client audits and FDA inspections. Show less
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Quality Assurance Auditor
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May 2014 - Feb 2015
- Audited raw data, study reports, and validation packages for compliance with Good Laboratory Practice (GLP) regulations and Standard Operating Procedures (SOPs). - Reviewed facility records and processes; pursued any perceived gaps in GLP compliance. - Reviewed vendor audits and submitted proposed responses. - Conducted critical phase inspections. - Issued Quality Assurance Statements to be included in the final Alizée reports upon completion of inspections in regulated studies.… Show more - Audited raw data, study reports, and validation packages for compliance with Good Laboratory Practice (GLP) regulations and Standard Operating Procedures (SOPs). - Reviewed facility records and processes; pursued any perceived gaps in GLP compliance. - Reviewed vendor audits and submitted proposed responses. - Conducted critical phase inspections. - Issued Quality Assurance Statements to be included in the final Alizée reports upon completion of inspections in regulated studies. - Attends and participated in local and national Quality Assurance training sessions and/or symposia. - Attended/co-hosted Sponsor or FDA audits and drafted responses to audits for submission to management. - Communicated with Sponsors on compliance issues and provided status reports for all studies managed. - Exercised independent judgment with regard to adherence to regulatory compliance.
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Research Associate and Project Manager
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Jan 2012 - May 2014
- Planned, organized, led, and controlled numerous studies for several different clients from quoting through final report signing. - Communicated with Sponsors and other outside contacts to ensure a high level of client satisfaction. - Provided support to Study Pathologists, Principal Investigators, and/or Study Directors for on-time delivery of high quality reports. - Principal responsibilities included: o Study setup (data tables, narrative, appendices). o Quality control… Show more - Planned, organized, led, and controlled numerous studies for several different clients from quoting through final report signing. - Communicated with Sponsors and other outside contacts to ensure a high level of client satisfaction. - Provided support to Study Pathologists, Principal Investigators, and/or Study Directors for on-time delivery of high quality reports. - Principal responsibilities included: o Study setup (data tables, narrative, appendices). o Quality control (QC) of data tables and reports. o Interfacing with the Quality Assurance Unit to ensure regulatory compliance of deliverables. o Collaborating closely with Executive Director and Pathologists or Study Directors to ensure that deadlines are met. o Management of project timelines and coordination of internal resources. o Communication with external clients regarding project status.
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Labratory Technician and Research Associate
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Feb 2011 - Jan 2012
- Supported laboratory production, mainly in the areas of medical device, toxicology, and immunohistochemistry work. Responsibilities included managing deadlines and Good Laboratory Practice (GLP) compliance of work for multiple lab functions. - Collaborated closely with the laboratory supervisors to ensure that all areas received adequate support and that all deadlines were met. - Maintained all equipment maintenance and repairs, maintenance of equipment records, and maintained and… Show more - Supported laboratory production, mainly in the areas of medical device, toxicology, and immunohistochemistry work. Responsibilities included managing deadlines and Good Laboratory Practice (GLP) compliance of work for multiple lab functions. - Collaborated closely with the laboratory supervisors to ensure that all areas received adequate support and that all deadlines were met. - Maintained all equipment maintenance and repairs, maintenance of equipment records, and maintained and promoted a tidy and safe laboratory environment. - Provided support to Study Pathologists, Principal Investigators, and/or Study Directors for on-time delivery of high quality reports. - Principal responsibilities included: o Study setup (data tables, narrative, appendices). o Quality control (QC) of data tables and reports. o Interfacing with the Quality Assurance Unit to ensure regulatory compliance of deliverables. o Collaborating closely with Executive Director and Pathologists or Study Directors to ensure that deadlines are met. o Management of project timelines and coordination of internal resources.
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Laboratory Technician
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Jun 2010 - Feb 2011
- Supported laboratory production, namely in the areas of medical device, toxicology, and immunohistochemistry work. Responsibilities included managing deadlines and Good Laboratory Practice (GLP) compliance of work for multiple lab functions. - Collaborated closely with the laboratory supervisors to ensure that all areas received adequate support and that all deadlines were met. - Maintained all equipment maintenance and repairs, maintenance of equipment records, and maintained and… Show more - Supported laboratory production, namely in the areas of medical device, toxicology, and immunohistochemistry work. Responsibilities included managing deadlines and Good Laboratory Practice (GLP) compliance of work for multiple lab functions. - Collaborated closely with the laboratory supervisors to ensure that all areas received adequate support and that all deadlines were met. - Maintained all equipment maintenance and repairs, maintenance of equipment records, and maintained and promoted a tidy and safe laboratory environment.
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Threshold Marketing
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United States
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Advertising Services
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1 - 100 Employee
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Project Supervisor
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Aug 2012 - Mar 2013
- Managed a team of customer service representatives throughout Frederick County, informing Potomac Edison customers of the energy saving programs and rebates currently taking place. - Used keen management and leadership skills to lead a successful team. - Managed a team of customer service representatives throughout Frederick County, informing Potomac Edison customers of the energy saving programs and rebates currently taking place. - Used keen management and leadership skills to lead a successful team.
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Mount Saint Mary's University
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United States
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Higher Education
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300 - 400 Employee
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Independent Study in Chemistry
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Jan 2010 - May 2010
- Researched BPA as well as other chemicals leeching from NalgeneTM and biodegradable cups made from corn material into different consumable matrices of varying pH. - Used high performance liquid chromatography in order to distinguish which chemicals were leeching from the containers into the surrounding solution.
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Resident Assistant
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Aug 2009 - May 2010
Worked as a university official to maintain the orderly resident halls of Sheridan 3rd North and 4th floors. Earned the highest number of programming points for fall 2009 and spring 2010 semesters of any Resident Assistant on campus while being a first year resident assistant.
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Technology Help Desk Student Technician
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Aug 2009 - May 2010
Repaired and upgraded Mount Saint Mary's issued Dell laptop computers as well as faculty computers and printers. Processed orders and requests of university officials.
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Undergraduate Research
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May 2009 - May 2010
- Collected data for fecal coliform count, total suspended solids, biochemical oxygen demand, pH, nitrate, and phosphate concentrations from a wastewater treatment plant. - Collected data of the species, color, and growth of the plants in the treatment plant. - Presented findings at the Mid Atlantic Chapter of the Ecological Society of America as a poster presentation.
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Peer Mentor
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May 2009 - Jul 2009
Advised incoming freshman in their courses and clarified any troubles. Facilitated the easiest possible transition into college.
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Internship
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Aug 2008 - Dec 2008
Explained environmental processes and coordinated nature walks. Encouraged children to be excited about nature and instructed environmental projects as well as explaining the significance of nature and its impact on human life. Explained environmental processes and coordinated nature walks. Encouraged children to be excited about nature and instructed environmental projects as well as explaining the significance of nature and its impact on human life.
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Education
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2011 - 2013
University of Maryland Global Campus
Master's degree, Enviromental and Risk Management -
2006 - 2010
Mount St. Mary's College
Bachelor of Science, B.S. Biology; B.S. Environmental Science
Community
