Jay Hastings
- Role
- Quality Assurance Specialist at Lampire Biological Laboratories, Inc
- Location
- Lancaster, PA, US
- LinkedIn followers
- 500 followers
About Jay Hastings
Senior Quality Assurance Specialist with 20 yrs experience with Quality Systems…
Experience
Quality Assurance Specialist
Lampire Biological Laboratories, Inc
Jul 2019 — Present
Performs Disposition on Raw Materials, Packaging Components and Consumables Perform Disposition of Finished Products Authors and Revises Standard Operating Procedures and Master Batch Records Approval of documentation and provide SME Support for Validation and Calibration Activities SOP Coordinator Administrator of batch record documentation including issuance, reconciliation, scanning and filing.
Education
Johnstown Career Technology Center
AS
1985 — 1986
Strayer University
BBA
2005 — 2009
Skills
- U.s. Title 21 Cfr Part 11 Regulation
- Glp
- Validation
- Gmp
- Biotechnology
- Trackwise
- Computer System Validation
- 21 Cfr Part 11
- Lims
- Clinical Trials
- Biopharmaceuticals
- Fda
- QA Compliance
- Pharmaceutical Industry
- Equipment Validation
- Verification and Validation (V&V)
- Gamp
- Laboratory
- Laboratory Information Management System (Lims)
- Change Control
- Quality Assurance
- Quality System
- Standard Operating Procedure (Sop)
- Software Documentation
- Regulatory Requirements
- Capa
- U.s. Food and Drug Administration (Fda)
- Sop
- Regulatory Submissions
- Cgmp Practices
- Technology Transfer
- V&V
- Document Management
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