- Merck & Co. (Rahway, NJ)
- …knowledge of pharmaceutics and drug development/design principles, as well as sterile fill finish processes, to ensure optimal automation in pharmaceutical ... or C for data management. Knowledge of pharmaceutics, drug development/design, and/or sterile fill finish . Familiarity and understanding with CFR, GMP, and data… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …In addition to drug substance manufacture, it will also provide automated fill - finish and assembly, packaging, and labeling services. The new state-of-the-art ... External US About This Role The QC LIMS Sr. Specialist 1 is accountable for support of the Laboratory...relevant scientific discipline 3+ years' experience working in a cGMP Quality Control department or in a FDA regulated… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …In addition to drug substance manufacture, it will also provide automated fill - finish and assembly, packaging, and labeling services. The new state-of-the-art ... preferably in Life Sciences or Engineering8 Years of direct experience in a cGMP manufacturing environment with an Associate's Degree6 Years of direct experience in… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill a QA Investigation Specialist position. This position performs all compliance related tasks vital to complete investigations and ... Reviewing completed batch records and logbooks in accordance with cGMP standards in support of investigations + Reviewing, editing,...amounts of relevant experience for each level: + Associate Specialist - 0-2 years + Specialist -… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …and a culture centered on diversity and inclusion. As an Associate Biotech Production Specialist , a typical day may include the following (but may vary greatly due ... and revises completed batch records, Logbooks, and SOPs in accordance with cGMP standards and aligned with written procedure + Performs manufacturing level… more
- United Therapeutics (Silver Spring, MD)
- …process and cleaning qualification for processes that may include Solid Dose, API, Fill Finish , and packaging + Utilize skill as an experienced validation ... and other orphan diseases. **How you'll contribute** The Senior Validation Specialist or Engineer, Equipment will perform activities independently in support of… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …manufacturing operations by applying function expertise. Current Departments with Openings: + Fill Finish Manufacturing + Manufacturing + Technical Operations In ... We are currently looking to fill multiple Change Control Specialist positions....Review, edit, and revise controlled documentation in accordance with cGMP standards + Coordinate and/or lead cross-functional meetings with… more
- Merck (Rahway, NJ)
- …knowledge of pharmaceutics and drug development/design principles, as well as sterile fill finish processes, to ensure optimal automation in pharmaceutical ... C for data management. + Knowledge of pharmaceutics, drug development/design, and/or sterile fill finish . + Familiarity and understanding with CFR, GMP, and data… more
- Novo Nordisk (Clayton, NC)
- …Finished Products (IFP) facility in Clayton, NC is a 457,000 square foot aseptic " fill and finish " site that is responsible for producing innovative, injectable ... change control documentation, SOPs & other current good manufacturing practice ( cGMP ) documentation + Provide coaching to Site regarding quality & compliance… more
- Novo Nordisk (Clayton, NC)
- About the Department You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, ... solid dosage forms, finished products, fill & finish warehousing, and QC across...industry trends to team and shop floor to drive cGMP + Facilitate problem solving, investigations, and process improvements… more
- Novo Nordisk (Clayton, NC)
- …Finished Products (IFP) facility in Clayton, NC is a 457,000 square foot aseptic " fill and finish " site that is responsible for producing innovative, injectable ... & Vendor Assessments required + Expert in current good manufacturing practice ( cGMP ) documentation practices. Requires a minimum of 8 years of experience in… more
- Novo Nordisk (Clayton, NC)
- …Finished Products (IFP) facility in Clayton, NC is a 457,000 square foot aseptic " fill and finish " site that is responsible for producing innovative, injectable ... Develop & manage calibration specifications & methods in accordance with cGMP , site/corporate procedures, policies, & business needs. Implement calibrations in SAP.… more
- Novo Nordisk (Clayton, NC)
- …Finished Products (IFP) facility in Clayton, NC is a 457,000 square foot aseptic " fill and finish " site that is responsible for producing innovative, injectable ... Maintenance activities, scheduled by Maintenance Planning, supported by Technical Area Specialist + Lead team in Event Response/RCA with assistance from the… more
- Curia (Albuquerque, NM)
- …equivalent work experience; and a * Minimum of 5 years in sterile injectable aseptic fill / finish work experience in a cGMP /FDA regulated environment, plus 2 ... Support (Compounding and Equipment Preparation) Supervisor, Equipment Mechanic, Production Control Specialist , and Set-up Mechanic. All activities for a shift are… more