- Hovione (East Windsor, NJ)
- …Best Practices. - Assure cGMP compliance before, during and after validation /qualification activities of systems /equipment and manufacturing processes by ... deviations, CAPA, improvement plans, and change control related to Qualification and Validation of Systems under her / his responsibility - Propose… more
- ThermoFisher Scientific (New Brunswick, NJ)
- …5, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes and computer ... Analyst (also referred to as a Scientific Software Compliance Specialist ) will be to provide validation support...to keep informed of computerized system needs, impact on computer validation , project validation status,… more
- Merck (West Point, PA)
- **Job Description** The Manufacturing Execution System (MES) Specialist acts as a subject matter expert and an area(s) site MES key point of contact, for Operations ... areas utilizing electronic Master Batch Records. The MES Specialist 's primary responsibility is to ensure that the deployment of the Korber PAS-X electronic Master… more
- Merck (West Point, PA)
- **Job Description** **Position Description:** **Senior Specialist , Digital Manufacturing Capital Project Management** The Senior Specialist (Digital ... delivered with appropriate technology and qualification standards. The Senior Specialist (Digital Manufacturing Capital Project Management) is responsible for… more
- Terumo Medical Corporation (Somerset, NJ)
- Sr Data Analytics Specialist Date: May 25, 2024 Req ID: 2337 Location: Somerset, NJ, US Company: Terumo Americas Holding, Inc. Department: IT3_Enterprise Business ... Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. **Job Summary** The Senior Data Analytics… more
- Bausch Health (Bridgewater, NJ)
- … Science, IT or related technical experience. + Minimum of 15 years of computer assurance/ validation experience in a regulated industry. + Minimum of 5 years ... a GxP regulated environment in addition to experience. + Experience with auditing Computer and/or Software Quality Management Systems . + Experience with leading… more
- Terumo Medical Corporation (Somerset, NJ)
- Camstar MES Design Specialist Date: May 27, 2024 Req ID: 2037 Location: Somerset, NJ, US, 08873 Company: Terumo Americas Holding, Inc. Department: SAP Leadership & ... Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. **Job Summary** This position will be… more
- Bausch Health (Bridgewater, NJ)
- …of improving people's lives with our health care products. The **Senior Specialist , External Manufacturing Quality** plays a crucial role in upholding compliance ... with Quality Systems governing externally manufactured products and processes across their...is required. + Training and experience in Supplier Management, validation , auditing, statistics preferred. Certified ASQ CQE and/or Lean… more
- Merck (West Point, PA)
- …platform administrator and Quality Management System (QMS) system administrator and configuration specialist . + Primary point of contact for the Veeva Vault QMS ... remains compliant as a Validated Solution through verification testing, documentation, and validation efforts + Collaborate across the Manufacturing & R&D IT Quality… more
- AbbVie (Branchburg, NJ)
- …are required to carry out. + Monitors operator training files and work with compliance specialist to keep files up to date. + Works with QA and Subject Matter Expert ... 8+ years' experience in all aspects of GMP manufacturing/ packaging processes + Computer proficiency and scheduling experience are required, as well as good writing… more