Priscilla Herpai

Freelance Voiceover Freelancer & Quality Assurance Freelancer

Location:Springfield, Pennsylvania, United States
2 Skills
Priscilla A. Herpai

? M.S. in Quality Assurance/Regulatory Affairs, Temple University, Philadelphia, PA
o 2013 – present
o GPA: 3.84
? B.S. in Marine Biology, Nova Southeastern University, Fort Lauderdale, FL
o 2003 – 2007
o Minors: Chemistry & Psychology

? Drug Development Certificate, Temple University, Philadelphia, PA
o June 2014


Globus Medical Audubon, PA
Quality Assurance Specialist Jun 2012 – May 2013
Left for FMLA leave, company unable to hold my position
? Performed Device History Record review and release functions and data analysis and trending
? Audited Design Master Records and Device History Files
? Reviewed certificates of compliance for test reports, technical and performance specifications, and receiving department inspection documentation
? Reported non-conformances and discrepancies
? Participated in vendor audits, inspections from Regulatory agencies, continuous improvement functions, and implemented changes for improvement
? Performed internal and external audits and created formal audit reports

Teva Pharmaceuticals Horsham, PA
Quality Assurance Auditor
Laid off Feb 2012 – May 2012
? Represented QA on cross-functional product development teams
? Reviewed batch records, product releases, validation protocols and reports, approved change control documentation, and approved manufacturing and laboratory investigations for contract and remote manufactured product
? Authored and maintained quality agreements for contract manufactured products
? Assisted with contract manufacturer audits

Fibrocell Science, Inc Exton, PA
Quality Assurance Specialist Aug 2011 – Feb 2012
Contract Position
? Reviewed and approved Manufacturing Batch Record documentation, Quality Control testing data, SOPs, and investigation and deviation reports
? Quarantine and final disposition of raw materials to manufacturing and Quality Control
? Conducted investigations through the use of problem solving tools
? Created reports, summaries, and certificates of analysis/compliance for final products
? Maintained CAPA program to ensure that potential problems and deviations had been resolved
? Performed internal and external audits to ensure adherence to regulatory guidelines
? Established and monitored Quality Assurance policies and procedures to ensure compliance

American Red Cross: Biomedical Services Philadelphia, PA
Quality Assurance Auditor Dec 2010 – Aug 2011
Laid off
? Reviewed, assessed and monitored records, processes, and systems at the critical control points in the manufacturing process
? Monitored the implementation and effectiveness of corrective actions
? Participated in external inspections/audits from regulatory and accreditation agencies
? Executed inspection readiness tasks prior to external inspections
? Performed quality audits of blood collection processes and laboratory activities
? Reviewed blood donor records and associated tests to ensure compliance and safety of the blood products
? Performed donor management to ensure donor and recipient safety
? Conducted investigations for deviations and implemented Process Improvement procedures to prevent recurrence

Gift of Life Donor Program Philadelphia, PA
Quality Assurance Coordinator Aug 2009 – Oct 2010
Left to further career as QA professional; no room for advancement
? Reviewed tissue and organ donor charts and potential donor assessments
? Ensured adherence to applicable regulatory and accreditation requirements
? Gathered and processed accurate donor information from laboratories, hospital staff, medical examiners, coroners, and other sources
? Coordinated with tissue processors to ensure safety and purity of donor tissue prior to release
? Performed donor management to ensure the safety of both the donors and the recipients
? Developed, implemented and maintained a new electronic database for the Quality Systems, such as NCRs, CAPAs, and complaints
? Identified areas of improvement based on extensive data analysis, trending, reporting, and presentation on individual and departmental statistics
? Performed internal and external audits to maintain clinical compliance with regulatory and voluntary accreditations

Charles River Laboratories Malvern, PA
Quality Assurance Coordinator Apr 2007 – Aug 2009
Company initiatives changed; layoffs announced for my department
? Reviewed raw analytical data and assessed the technical content prior to final QA review
? Performed laboratory audits and provided data analysis and trending reports on audit findings
? Provided guidance and responded to queries from internal and external audits
? Ensured all laboratory trials were performed and documented per protocols and SOPs
? Developed Quality Control and Analytical SOPs
? Performed laboratory investigations and developed corrective action plans

Fisher Clinical Services Allentown, PA
Quality Assurance Inspector Oct 2006 – Apr 2007
Contract position
? Ensured that only high quality products moved through production lines
? Conducted a range of in-line tests to ensure adherence to SOPs and Batch Records
? Staged and reconciled products and components used for production
? Performed production run data analysis and trending

? ASQ member
? Microsoft Office and Microsoft Windows applications
? cGMP, cGLP and cGTP
? Quality Systems Management
? Quality and Process Improvement
? Quality audits
Skills (2) Rating
Quality Assurance