Kevin M. Parks
QA Professional at Regeneron Pharmaceuticals, Inc
- Role
- Staff Qa Validation Specialist at Regeneron
- Location
- Albany, NY, US
- LinkedIn followers
- 500 followers
About Kevin M. Parks
Quality Assurance professional experienced with biologics, small molecule, and devices (ISO 13485/ISO 9001) including DS, DP (aseptic processing liquid – vials and PFS – and lyophilized), and packaging. Provided quality oversight (person in plant) of CMO/CTL sites that included Quality/Technical Agreements, MBR, technology development/transfers, and process validations.Qualified vendors by leading audits (US, EU, and Japan)- CMO, CTL, service providers, and suppliers (containers closures and excipients) and supported filings/updates, CMC teams, and assisted with regulatory body inspections. Experienced with Quality System elements that included change management, deviations/CAPA, investigations (OOS/OOT, media fill/sterility failures), complaints, APR/PQR, batch record review (MES and paper), method validations/transfers and product suitability, disposition (US and EU – working with QP), risk assessments (FMEA/HACCP) and experienced with US/International regulations/directives for Phase (I to clinical/commercial products. Experienced with aseptic processing that included media fill, gowning, container closure integrity, and shipping studies and operation and qualification/validation of cell based processing equipment/skids, cleaning (CIP) and sterilization (filter, autoclave, ETO, gamma, VHP and SIP), isolators/RABS/cleanrooms, and critical utilities.Specialties: Quality Systems, biologics, aseptic processing, and auditing
Experience
Staff Qa Validation Specialist
Mar 2023 — Present · Albany, NY, US
Education
University of Wisconsin-Stout
BS, Engineering, Food Science
University of Wisconsin-Madison
MS, Food Microbiology
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