- Cardinal Health (East Rutherford, NJ)
- …**_Responsibilities_** + Works in compliance with all regulatory standards including EHS, cGMP , Radiation Safety, applicable FDA and pharmacy laws, DOT, and internal ... Operating Procedures (SOPs) in accordance with current Good Manufacturing Practices ( cGMP ) requirements including Good Documentation Practices (GDP) + Monitors and… more
- ABM Industries (Millburn, NJ)
- …ABL site specific SOP's + Assist Supervision with internal pre-audits walkthroughs, CGMP housekeeping and general organization and upkeep of manufacturing spaces + ... **Preferred Skills** + Thorough understanding of regulatory requirements for cGMP manufacturing facility, especially as they apply to cleaning practices/sterility… more
- Actalent (Princeton, NJ)
- …operations, including in-process checks, deviation identification, and adherence to cGMP expectations. + Ensure all manufacturing activities comply with GMP ... Skills & Qualifications + CDMO experience is strongly preferred. + Strong knowledge of cGMP regulations (21 CFR Parts 210, 211, 1271), and relevant ICH and FDA… more
- Bristol Myers Squibb (Summit, NJ)
- …components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing ... purification, and aseptic processing or lab technique. + Knowledge of cGMP /FDA regulated industry. + Basic mathematical skills - General understanding of… more
- Actalent (Princeton, NJ)
- …Quality Control operations in the Analytical and Microbiological laboratories within a cGMP environment. The Quality Control Supervisor will be fully qualified on ... executed on time, to the highest quality standards, and in compliance with cGMP . The position supports both the Princeton and Newark sites, providing direct quality… more
- Bristol Myers Squibb (Summit, NJ)
- …components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing ... purification, and aseptic processing or lab technique. + Knowledge of cGMP /FDA regulated industry. + Basic mathematical skills. + General understanding of… more
- Actalent (Allendale, NJ)
- …QC Analytical Supervisor will organize, and direct staff to meet and exceed cGMP requirements, and establish KPI's, while adhering to quality control and technical ... or equivalent. + Strong knowledge of FDA and EU regulatory standards. cGMP experience required. + Strong knowledge of analytical test methods and philosophies.… more
- Bristol Myers Squibb (Summit, NJ)
- …**Knowledge & Skills:** + Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance. + Demonstrated ability to work in an ... Disposition experience required. + A minimum 8-years relevant work experience within a cGMP environment. + A minimum 3-years of people leadership experience in the… more
- J&J Family of Companies (Raritan, NJ)
- …in a manner consistent with the safety policies, quality systems and cGMP requirements. + Other duties can be assigned, as necessary. **Qualifications:** ... + Minimum 2 years of relevant work experience + Knowledge of cGMP regulations and FDA/EU guidance + Strong communication (verbal, written, and presentation)… more
- CSL Plasma (Clifton, NJ)
- …* Leads internal audits to monitor facility compliance with SOPs, cGMP , OHSA, FDA, and other regulations, as applicable Qualifications: * Bachelor's/Associate ... or equivalent of 1-year experience in a regulated environment * Knowledge of cGMP , OHSA, FDA, and other applicable regulations * Strong customer service skills *… more