- University of Rochester (Rochester, NY)
- …GENERAL SUMMARY Possess an advanced understanding of current Good Manufacturing Practices ( cGMP ) as defined in 21 CFR FDA regulations and apply those to ... Unit. Expected to work independently with minimal guidance in the areas generating SOP's, Process Orders and CMSS documents. This position may sit in on client team… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and accurate data. + Ensures all revalidation requirements are met for equipment, process and cleaning site wide. + Ensures responsible group remains compliant with ... Safety, Performance Development, Quality Stewardship, SOP read and Review, and cGMP training requirements. + Manages validation activities for large scope capital… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill an Associate Director of GMP Compliance & Inspections position. This position will work with cross-functional teams to drive ... you: + Are knowledgeable in industry practices and regulations ( cGMP , Annex I) and across multiple health authorities (eg...each level: + Sr Manager - 8+ years + Associate Director - 10+ years May substitute… more
- Fujifilm (College Station, TX)
- …task, role, responsibility as directed by Director or Associate Director , PMO. **Required Skills & Abilities:** . cGMP experience and working knowledge ... performance indicators, ensuring transparency and accountability. . Drive continuous process improvement initiatives, RCAs, sharing best practices and lessons… more
- Catalent Pharma Solutions (Kansas City, MO)
- …Equipment Qualification documents for the Kansas City PCH-EP Business, and assists the Associate Director , Quality Assurance in review and approval of Cleaning ... and Process Validation documents. In addition, Quality Engineer II, Validation...engineering sound and in compliance with all + FDA QSR/ cGMP , ISO, and Quality Policies of the company **The… more
- Unither Pharmaceuticals (Rochester, NY)
- …It has more than 280 employees. Your role Reporting to the Quality Director , JOB SUMMARY: This is a team-oriented position with the individual actively coordinating, ... with the approved report(s) within the appropriate project folder throughout the process of validating a system. Develop a standard operating procedure specific to… more
- Novo Nordisk (Petersburg, VA)
- …activities associated with changes to existing & new systems. Process equipment supported includes propagation, fermenters, media sterilizers and supporting ... & timely completion of all deliverables. Relationships Reports to Manager, Director . Essential Functions + Perform, review & approve validation/revalidation & PSE… more
- Lilly (Indianapolis, IN)
- …to GMP operations at Indianapolis Parenteral Manufacturing. The Sr. Manager assists the Associate Director in managing daily work of personnel and tracking ... for individual contributor activities that may include SME and Process Owner within area of responsibility as well as...Services, Engineering or Regulatory is desirable + Knowledge of cGMP 's + Technical writing and written communication skills are… more
- Lilly (Indianapolis, IN)
- …world. **Responsibilities:** The Sr. Manager Logistics Quality will report to the Associate Director Regional Logistics Operations QA. The Senior Manager ... manufacturing sites representatives to determine acceptability. . Oversee the GMP Waste process for materials located at the warehouse. . Supervise the management,… more
- Amgen (Holly Springs, NC)
- …Carolina commercial product release. The Specialist QC Support will report directly to the Director of Quality Control and as a member of this leadership team, you ... **Change Control** + Develop and manage the change control process at ANC in line with FDA, EU GMP,...and 10 years of Quality Control experience OR + Associate 's degree and 8 years of Quality Control experience… more