Jennifer Perrin has over 15 years of experience in quality systems for manufacturing pharmaceuticals and medical devices. She currently serves as the North American Manufacturing QA Manager for AMRESCO, overseeing quality assurance staff across five sites. Prior to this role, she held various quality assurance and change management positions with increasing responsibility at Ben Venue Laboratories and AMRESCO. She has extensive experience ensuring regulatory compliance, approving documentation changes, and managing supplier quality programs.

1. Jennifer M Perrin
14172 Mayfield Road
Huntsburg, OH 44046 jenmperrin@hotmail.com Cellular: 440-554-8256
EDUCATION
Lean Six Sigma Black Belt Kent State University, June 2011
Bachelor’s Psychology/Biology minor Cleveland State University, May 1997
PROFESSIONAL SUMMARY
Quality Systems Professional with 15+ Years of industry experience
14+ years of supervisory experience
• Manufacturing, Packaging, Quality Control
Laboratory
• Parenterals (sterile liquids, lyophilized)
• Medical Devices
• Change Management
• Extensive contract customer contact
• Excipient Processing
• Validation (Process, Computer)
• Quality Assurance (OOS, CAPA, SOP’s,
MBR’s, cGMP Audits)
• Regulatory Compliance/Regulatory Affairs
(ANDA’s)
• cGMP Training Coordinator
• Quality Systems Training
• ISO Lead Auditor Certification (CALISO)
• Supplier Quality
Computer skills: TrackWise, Documentum, ERP Systems, AMMS (inventory management), EtQ Reliance,
StarLims, CheckPoint Monitoring System
CAREER HISTORY
June 2014- Present
AMRESCO, LLC/ VWR
Manufacturer and Supplier of High Quality Biochemicals and Reagents, Medical Devices and
Excipients
Promotion
North American Manufacturing QA Manager
July 2015- Present
• Manage QA staff across five (5) North American sites
• Provide site support for critical customer and regulatory audits
• Working towards gaining EXCiPACT Certification for Solon site
• Support SAP implementation at multiple sites as it pertains to document
management
• Monitor compliance of Quality Management Systems (QMS) across North
American sites
• Align QMS across North American sites
• Obtain ISO certification for Aurora site
• Perform site audits of critical suppliers (domestic and international)
• Approve supplier desk audits
• Align Supplier Qualification Program across multiple sites
Promotion
Global Supplier Quality Engineer
March 2015 – July 2015
• Perform site and desk audits of suppliers
• Obtain necessary documentation for supplier qualification
• Initiate and monitor Supplier Corrective Action program
• Approve evaluations for new materials and suppliers
Promotion
Senior Supervisor Quality Assurance August 2014- March 2015
• Manage staff of 20 salaried personnel
• Approve complaint and non-conforming material investigations
• Staff development
• Approve deviations
• Review/approve change packages
• Facilitate CAPA Review Board
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2. Jennifer M Perrin
14172 Mayfield Road
Huntsburg, OH 44046 jenmperrin@hotmail.com Cellular: 440-554-8256
• Maintain FDA product listings
• Conduct supplier audits
• Conduct internal audits
• Host customer and regulatory audits
• Approval validation protocols
Non-conforming Materials Coordinator June 2014- August 2014
• Manage quarantine process
• Disposition product
• Conduct investigations
• Facilitate the Material Review Board
Ben Venue Laboratories - Bedford, OH July 2000 – November 2013
Contract Manufacturer of Sterile Pharmaceuticals
Specialist, Technical Compliance Apr 2013-November 2013
• Corroborate with Engineering, Metrology and Maintenance Departments to develop changes
relating to controlled documents (SOPs, batch records, methods, specifications), equipment,
utilities(WFI, HVAC, Nitrogen), and facilities.
• Track metrics of groups to ensure timely closure of records
• Track training compliance of groups to ensure the site goal of 98% compliance was met
• Manage controlled document changes in IDEA for CON (Documentum)
Promotion:
Supervisor, Change Control
Mar 2011- Apr 2013
• Manage staff of 20 (12 salaried and 8 hourly)
• Coach CC Specialists regarding change management decisions
• Staff development
• Oversee TrackWise system in terms of health of Change Management process
• Approve deviations
• Review/approve change packages
• Facilitate Change Control Review Board
• Project Management
Promotion:
Senior Change Control Specialist
Dec 2010- Mar 2011
• Review/ approve change controls (focus on Production) for accuracy. Assess change packages for
risk and impact to regulatory filings, validation, product quality etc.
• Train CC Specialists
• Process Controlled Documents
• Create/Maintain Controlled Document Workflows in IDEA for CON (Documentum)
Change Control Associate Oct 2009-Dec 2010
• Review/ approve change controls (focus on Production) for accuracy.
• Assess change packages for risk and impact to regulatory filings, validation, product quality etc.
• Change Control Team Lead on the Batch Record Re-design project
• Change Control Team Lead on the Phase V and Technical Remediation South Complex SOP
project
Supervisor, Equipment Preparation June 2005-Oct 2009
• Managed staff of 30 (hourly personnel)
• Review of preparation records for accuracy
• Verifying correctness of equipment preparation process
• Overseeing the decontamination procedure
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3. Jennifer M Perrin
14172 Mayfield Road
Huntsburg, OH 44046 jenmperrin@hotmail.com Cellular: 440-554-8256
• Working very closely with Sterilization and Aseptic Filling departments to coordinate the correct
processing/utilization of equipment
• Initiating a bar-coding inventory system
• Working closely with the Validation Department regarding the qualification of equipment
• Coordinating efforts with the Product and Process Development Department with development of
new/revised cleaning procedures for products.
• Approval of Master Production Records
Promotion:
Supervisor, Quality Assurance
June 2001- May 2005
• Managed staff of 6 (salaried personnel)
• Working very closely on a daily basis with Production, Packaging, Quality Control, Lyo-Sterilization,
Component Control, Warehouse, Component Preparation, Formulations, and Product and Process
Development departments to ensure customer and regulatory agency compliance at all times.
• Disposition of process deviation reports and red-tag reports generated as a result of abnormal
occurrences during the manufacturing process.
• Writing and reviewing of customer investigations.
• Lead auditor performing internal audits.
• Scheduling auditors and reviewing internal audit reports.
• Assisting Process Validation department with validation study issues.
• Solely responsible for interviewing, hiring and training of new auditors.
• Trained in root cause analysis, ANSI/ASQ Z1.4-2003, Z1.9-2003 and CAPA program.
• Well versed in 21 CFR part 11, 210, 211, 820 and current FDA guidance relating to the
pharmaceutical industry.
Quality Assurance Auditor July 2000- June 2001
• Training/cross training employees and assuring company-wide compliance to all FDA and customer
regulations regarding the production of sterile injectable pharmaceutical products.
• Numerous reporting mechanisms.
Marconi Medical Systems Nov 1999 - July 2000
Associate Buyer/Planner
• Planning and purchasing of medical equipment for regional warehouse.
• Expediting of suppliers.
• In charge of accounts payable, Imports/export discrepancies. BAAN trained. Receiving issues.
Critical parts issues. Excel spreadsheets.
CERTIFICATIONS MEMBERSHIPS
ISO9000 Internal Auditor Parenteral Drug Association (PDA)
Internal Auditor Certification, Applied Quality Systems American Society for Quality (ASQ)
Lean Six Sigma Black Belt
Microsoft Excel, Work, Adobe Advanced Certification; Tri-C
Corporate College
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