Resume

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 & Regulatory Professional with 19+ Years of industry experience
18+ years of supervisory experience
• Manufacturing, Packaging, Quality Control
Laboratory
• GMP Development & Audits
• Parenterals (sterile liquids, lyophilized) &
Contract Manufacturing/Branded Products
• Regulatory Compliance/Regulatory Affairs
(ANDA’s)-BSE/TSE, REACH, ROHS+
• Change Management • cGMP Training Coordinator
• Extensive contract customer contact
• KPI Development & Tracking
• Quality Systems Training
• ISO Lead Auditor Certification (CALISO)
• Risk Assessment & Validation (Process,
Computer)
• Supply Chain Management – Raw Material
Approvals & SDS Reviews
Computer skills: TrackWise, Documentum, ERP (MFG-Pro), AMMS (inventory management), EtQ, SAP
CAREER HISTORY
PolyOne January 2017-Present
Specialized Polymer Formulator and
Raw Material Supplier
North American Product Stewardship Manager/ Global REACH Compliance Manager
• Lead team of direct reports with responsibility for coaching, development, and performance
appraisals.
• Develop and maintain regulatory standards to ensure compliance with all applicable regional law,
regulations, and appropriate directives.
• Monitor developments in subject regulations to assure the company can anticipate and support
changing regulation and impact to the portfolio or product pipeline.
• Develop and execute appropriate risk management strategies designed to identify potential risk,
evaluate consequences, and provide solutions to adequately address regional business needs.
• Manage to a monthly budget and consider financial implications of regulatory decisions on a
regional basis.
• Interface with governmental authorities for the discussion of adverse events, general questions or
any related issues.
• Work with internal and external legal counsel when required
• Develop curriculum and associated training materials for the regional product stewardship team
and other PolyOne teams as needed.
• Liaise and coordinate regional activities associated with management systems such as
Responsible Care.
• Develop and implement global REACH compliance program.
Ricerca Biosciences October 2015-January 2017
Contract Organization
Pharmaceutical Manufacturer
GMP QA Manager
• Develop, mentor and supervise GMP QA Group, and provide regulatory consultation and training of
operational and QA staff
• Maintain knowledge and understanding of applicable FDA and ICH regulations, Global Regulatory
standards, and/or guidances.
• Utilize feedback from external and internal audits/sources to drive continuous improvements and
Page 1 of 4

2. Jennifer M Perrin
14172 Mayfield Road
Huntsburg, OH 44046 jenmperrin@hotmail.com Cellular: 440-554-8256
monitor emerging regulatory issues
• Prepare, review, and/or update the Quality Assurance Standard Operating Procedures related to
cGMP and regulatory operations.
• Monitor progress and completion of deviations, investigations, CAPAs, etc. and provide trend
reports to management as requested.
• Audit Master Batch Records, Production Batch Records, and release and stability data for
compliance with applicable procedures; report and resolve audit findings and maintain appropriate
records and reporting.
• Assist in the hosting of federal agency or client inspections relating to cGMP and regulatory
compliance.
• Oversee the Vendor/Supplier Qualification program for all applicable raw materials and finished
goods.
AMRESCO, LLC/ VWR June 2014- October 2015
Manufacturer and Supplier of High Quality Biochemicals and Reagents
Promotion
Senior Global Supplier Quality Manager March 2015- June 2015
• Manage QA Staff at three (3) North American sites
• Conduct supplier audits and raw material approval process
• Host Regulatory and Customer audits at all North American sites
• Facilitate obtaining ExCIPACT ISO certification for two (2) North American sites
• Work with legal counsel for significant non-compliance events (regulatory or medical)
• Developed global plan for roll-out of IT software related to raw material approval/review+
Promotion
Senior Supervisor Quality Assurance August 2014- March 2015
• Manage staff of 20 salaried personnel
• Approve complaint and non-conforming material investigations
• Staff development and training
• Approve deviations
• Review/approve change packages beginning w/ SDS reviews
• Facilitate CAPA Review Board
• Maintain FDA product listings & contribute to resolution of adverse events/consent order activity
• Conduct supplier audits
• Conduct internal audits
• Host customer and regulatory audits
• Approval validation protocols
Non-conforming Materials Coordinator June 2014- August 2014
• Developed, managed and crafted training for quarantine process
• Disposition product
• Conduct investigations & risk assessments
• 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)
Page 2 of 4

3. Jennifer M Perrin
14172 Mayfield Road
Huntsburg, OH 44046 jenmperrin@hotmail.com Cellular: 440-554-8256
• 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
• 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.
Page 3 of 4

4. Jennifer M Perrin
14172 Mayfield Road
Huntsburg, OH 44046 jenmperrin@hotmail.com Cellular: 440-554-8256
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
Page 4 of 4