Sean Holmes
Quality Assurance Specialist at Regeneron Pharmaceuticals, Inc.
- Role
- Principal Quality Specialist at Regeneron
- Location
- Rensselaer, NY, US
- LinkedIn followers
- 500 followers
About Sean Holmes
Highly detailed QA/QC professional with 25+ years’ experience in providing process, equipment, system validation and testing. Seasoned in AQL inspections, Corrective And Preventive Action, root cause analysis and handling class II-V controlled substance within DEA/FDA/OSHA requirements. Skilled in supervising/training staff, data reporting and ensuring product specs are met. Able to leverage analytical and results-focused abilities to create efficient SOPs, finished product/incoming raw materials QA systems and protocols for deviated batches. Reputation for resolving issues taking into account time, budget and the most proactive manner possible.Corrective/Preventive Action • CAPAProject Management • Protocol Design/Testing • Technical Writing • Compliance • Master Planning • SOPs • cGMPs/ISODocumentation/Reporting • Data Management • Evaluation/Analysis • Tracking • Electronic Test/Measurement Equipment Probes • Optical Power Meters • Spectrum Analyzers • Weigh-In Functions • Bacteria/Mold Counts • Preliminary/Final Audits Batch Records/Releases • Presentations • Finished Product Specifications • Raw Materials • In-Process Inspections
Experience
Principal Quality Specialist
Jan 2021 — Present
Education
Ashford University
Bachelor of Business Administration (BBA)
2008 — 2012
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