Joseph Oosterman
- Role
- Quality Systems Specialist at Denison Pharmaceuticals
- Location
- Providence County, RI, US
- LinkedIn followers
- 500 followers
About Joseph Oosterman
I am a highly dedicated, honest and respectful person who has been part of great teams…
Experience
Quality Systems Specialist
Jun 2017 — Present
As a Quality Systems Specialist, I am part of a team that reviews testing data, stability protocols, IQ/OQ/PQ documentation, master batch records, certificates of analysis, deviations, change controls, CAPA and drug release documentation ensuring safety, quality, identity, purity and potency of over the counter (OTC) drugs, homeopathics and cosmetics before being released to the public. I review changes to product specifications and packaging specifications to ensure GMP and compliance to vendor specifications. I improve compliance to current GMPs by revising and writing applicable Standard Operating Procedures (SOPs). I manage and review deviations, investigations and corrective/preventative actions in ensur, closing within 30 days to ensure compliance. I conduct internal audits, ensuring GMP and ensuring all issues are resolved.
Skills
- Quality System Compliance
- Sop
- Validation
- Good Clinical Practice (Gcp)
- Change Control
- Cell Culture
- Aseptic Processing
- Quality Control
- Lims
- Fda
- Sales
- Pharmaceutical Industry
- Gmp
- Quality Auditing
- Capa
- Quality System
- Customer Service
- Glp
- U.s. Food and Drug Administration (Fda)
- Gxp
- Life Sciences
- Deviations
- Biotechnology
- Purification
- 21 Cfr Part 11
- Biopharmaceuticals
- Research and Development (R&D)
- Quality Assurance
- Trackwise
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