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Quality Assurance Manager

Allen Park, Michigan, United States
October 16, 2016

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Lisa Claxton

**** ********, ******* ****, ** ****6


Professional Summary:

I have extensive experience working in Government Regulated Industries. My experiences in the areas of Finished Pharmaceutical Manufacturing, including Aseptic Processing, Quality Systems Management and Implementation, Supervision of a Clinical Laboratory, QA within a Plasma Collection Center, including auditing of Medical Records, Internal/External Auditing, GMP and Safety Training, Auditing of Quality Control Analytical Data Packages for Final Product Release, Auditing of Validation Reports for Test Methods and Manufacturing Equipment, Customer Complaint Handling/Pharmacovigilance and Document Management have been extensive. I have successfully increased the standards of quality and compliance in every position I have held and I am ready to contribute to the success of your organization.


B.S. in Chemistry,

University of Missouri, Rolla, Rolla, Mo.

Other Studies Include Chemical Engineering Courses: Thermodynamics, Physical Chemistry, Heat Transfer, Fluids, and Chemical Engineering Calculations

A.S. in Engineering Science,

St. Louis Community College at Meramec, Kirkwood, Mo. Wayne State University, Detroit Mich.

Studies Included: Biology, Microbiology and Biochemistry Additional Training:

"How to Supervise People" Fred Pryor

"Sexual Harassment Issues in the Workplace" University of Missouri, Columbia

"Conflict Management" University of Missouri, Columbia

"CLIA Regulation" GMP Institute

"Train the Trainer, Train the Auditor and ISO Certification" GMP Institute

"Contamination Control," Anne Marie Dixon

“Adverse Drug Experience Reporting,” RAPS

“Auditing Techniques for CR Monitors & Managers & QA Professionals,” Barnett

“Developing Competitive Advantage with Executive EQ,” Robert K. Cooper, Ph.D.

“Essentials of Credibility, Composure & Confidence,” Skill Path Summary of Experience:

Avomeen Analytical Services

Manager, Quality Assurance, May 2016 to Present

Responsibilities include but are not limited to:

o Managing the Quality Systems under GMP/GLP/ ISO 17025 Regulations and Guidelines o Manage the companies Calibration and Preventative Maintenance Program o Manage the Internal and External Audit Program

o Document Control and Management

o Review and approval of SOPs, Policies, Test Methods, Protocols and Final Reports o Focus on maintaining an acceptable level of Compliance with all applicable Laws and Regulation Lisa Claxton


Sun Pharmaceutical Industries, Inc. (a.k.a. Caraco) {Closure of Manufacturing Plant - Layoff.} Medical Affairs Associate – Pharmacovigilance, January 2015 to December 2015 Asst. Mgr. – QA, Document Control & Training, December 2011 to Jan 2015 QA Supervisor III Manufacturing Operations, February 2009 to December 2011 Responsibilities and Accomplishments included but are not limited to: o Started with auditing in the Manufacturing Areas to work on compliance issues. Shortly after my arrival, under the direction of the FDA, the Company suspended all manufacturing operations in September 2009. o After Caraco voluntarily entered into a consent decree with the FDA, I and my colleagues diligently worked to achieve cGMP Compliance to allow the company to resume manufacturing. In Late 2011 we obtained FDA approval to begin manufacturing our first revalidated product. o During the shutdown, I worked with Lachman Consultants Group, and all Management personnel from each department to perform and complete a Gap Analysis of the current Quality Systems. o Assisted in developing Work Plans for fixing the identified gaps - determined what was needed for closing the gaps and assisted with preparing the new Quality System processes and procedures. o Participated with generating and implementing Critical Improvement Plans for Quality Systems. o Managed/executed critical Training Improvement Plans and generated Quarterly Reports updating Sr. Management. o Continued by developing, writing, training on, implementing, and maintaining the new quality systems: With the Consultants, we wrote the new Change Control Program, Planned Events Program, Quality Assurance Oversight Processes within the Manufacturing Areas, and Packaging and Warehouse/Material Storage Areas. Developed the process of auditing of BMRs/BPRs and the process for performing AQL Inspections of the Final Product. o Wrote Training Modules and conducted both Classroom and OJT training for QA and Manufacturing personnel including qualifying other to become Classroom and OJT Trainers. o Worked closely with Lachman Consultants and Facilities and Engineering to qualify the newly installed Purified Water Generation, Storage and Distribution System. o After startup, I was made the Asst. Manager of QA, Document Control and Training and continued to maintain Compliance with all applicable quality standards and regulations. o In May 2014, Sun Pharma announced the closure of the Manufacturing facility. I was transferred into the Regulatory Affairs Global Pharmacovigilance Group until that group was also closed down. Talecris, Plasma Resources {Company decided not to open the new Plasma Collection Center - Layoff.}

Senior Quality Assurance Associate, January 2008 to December 2008 Responsibilities and Accomplishments included but not limited to: o Supervision of the Quality Control/Quality Assurance processes and procedures within a Plasma Resource/Collection center.

o Audited all the patient records and execution of the written procedures to ensure compliance with all Talecris’ internal policies and procedures and ensured compliance with all regulatory requirements under 21CFR Part 606, Current Good Manufacturing Practice for Blood and Blood Components. o Completed a detailed Training Program within the 3 months allotted and became certified as a Talecris Compliance Auditor.

Ash Stevens, Inc. API Manufacturing {Layoff.}

Senior Quality Assurance Associate, June 2003 to December 2007 Responsibilities and Accomplishments Included but not Limited to the Following: o Performed detailed audits of analytical test method validation packages from the Analytical Development Group and OQ/PV validation packages from the QC Laboratory. Lisa Claxton


o Implemented, executed and maintained the quality systems within Ash Stevens to ensure compliance with regulatory requirements as propagated by the United States Food and Drug Administration and other similar bodies.

o Assignments included auditing of batch manufacturing records and analytical data packages to ensure data met all required specification.

o Completed the final assembly of all batch documentation and approved the APIs for release to the customers - Ash Stevens is a third party manufacturer of APIs primarily used as experimental cancer treatments. o Created final C of As and supervised shipment of the released API to the customer. o Wrote, reviewed, approved and implemented new or revised procedures to support all Quality Assurance efforts. o Performed internal audits to ensure that Ash Stevens drug regulatory requirements were met. o Trained Ash Stevens personnel to meet GMP requirements. o Worked with the Innovators to ensure Ash Stevens met all their needs and requirements. Abbott Laboratories, Wyandotte, Michigan {Professional advancement.} Document Control and Quality Assurance Manager, February 1998 to June 2003

Responsibilities and Accomplishments Include but are not Limited to: o Developed GMP Systems such as issuing, controlling and archiving of batch records, pest control, housekeeping, managing the Document Center, issuing and controlling labeling materials, and managing facility wide training. o Assisted with the development and writing of the Master Batch Records. o Developed and implemented the internal cGMP and Safety Training program including creating and conducting monthly cGMP Training sessions.

o Set up and managed the entire Document Control Area. o Organized the Document Center to ensure ease of tracking and retrieving of all documentation. o Created and implemented the APR and Internal Audit Programs. o Implemented a CA/PA Program for the entire facility including ensuring all action plans were tracked to completion.

o Participated is a site wide Training Initiative to ensure all new personnel coming onto the BASF Sight, to work for Abbott or BASF, received a comprehensive Sight Wide Orientation that was applicable to Safety, GMP and Job Skills Training applicable to their Job Function

o Wrote and performed training on cGMP and trained on an Introduction to Chemistry. Ferndale Laboratories Inc., Ferndale, Michigan {Professional advancement.} Manager, Quality Assurance, June 1992 to February 1998 Responsibilities and Accomplishments Include but are not Limited to: o Started, executed and later managed a facility wide Training Program for all departments within the facility, managed the training files, and managed the training information data base. o Started, executed and later managed a Consumer Complaint Program. o Started, managed and assisted in executing an External Vendor Audit Program. o Started, executed and later managed an Internal Audit Program. o Wrote, Revised and Approved SOPs and MBRs.

o Daily, Assisted in Facility Wide Compliance Issues. o Member of the SOP, MPR, Specification, Label Copy Approval, Cleaning Validation and Production Planning Committees.

o Managed the Incoming QA and Operation's Auditors performing AQL inspections and auditing of the executed manufacturing batch records.

o Approved the Finished Product Releases for distribution to the market. Lisa Claxton


University of Missouri, Columbia, MO {Moved to return home to Michigan.} Supervisor of Laboratory Services, January 1992 to June 1992 Responsibilities and Accomplishments Include but are not Limited to: o Supervised a RIA (Radio Immuno Assay) Laboratory. o I was hired to bring the Laboratory into compliance with the CLIA Regulation - The Laboratory successfully passed an audit prior to my departure.

o Prepared the lab for the receipt of large numbers of Blood and Serum Samples from different Clinical Sites who were executing Experimental Protocols for various Pharmaceutical Companies. o Attended meetings with the Pharmaceutical Companies regarding their Clinical Trial Protocols. o Ran RIA tests for Insulin, C-Peptide and Glucagon. o Responsible for Employee Evaluations and Training. o Audited Logbooks and Assay Results to ensure Conformance to CLIA Regulations. Survival Technology, Inc., Brentwood, MO {Relocated for professional advancement.} Lead Manufacturing Supervisor, Sterile Operations, January 1987 to January 1992

Responsibilities and Accomplishments Include but are not Limited to the Following: o Supervised the Packaging, Formulation and Aseptic Filling of Several Currently Marketed Parental Drugs within a Union Environment.

o Revised SOPs and Batch Records.

o Trained Technicians on Safety and GMP Issues.

o Audited Batch Records and Wrote Deviations.

o Handled Union Issues and Scheduling of all Sterile Manufacturing Operators. o Was involved in a large scale up of the facility due to an overwhelming demand of the newly marketed product, Toradol.

o Trained other Manufacturing Supervisors when we went from a one shift to a two shift, then later, a three shift operation due to the high demand of the antidote to nerve gas during the Desert Storm War. o Trained then assisted in the qualification of all personnel for authorization of their entry into the sterile manufacturing area

o Also received training in the Formulation, Clean & Prep, and Packaging Areas for a full understanding of the facilities operations.

Monsanto Animal Science Div., Chesterfield, MO {Professional advancement.} Research Assistant, 1986

o Worked with the Following Processes:

o Aseptic Formulation and Filling within a Pilot Plant manufacturing drugs for animal injection. o Assisted in the Fermentation and Lyopilization Areas. o Assisted During Ultrafiltration for Protein Purification. o Set up Digi-Strip for CIP Operations.

o Received Safety and GMP Training.

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