- Amneal Pharmaceuticals (Piscataway, NJ)
- …methods and standard protocols, maintaining full compliance with all applicable US FDA - cGMP regulations and internal SOPs. + -Utilize techniques of ... to technical problem solving and troubleshooting as needed. + Contribute towards optimizing laboratory operations to increase efficiency and GMP compliance. more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …specific components of departmental strategic initiatives. . Responsible for maintaining GDP, GMP , and global trade compliance . Implement and carry-out vision and ... comparator drugs and other co-meds for clinical studies . Mature knowledge of the FDA , cGMP, GCP standards and regulatory guidance documents such as CFR, Annex 13. .… more
- Balchem (Montvale, NJ)
- …(EPA), Equal Employment Opportunity (EEO), and Federal Food and Drug Administration ( FDA ) regulations. + Ability and willingness to learn, understand, follow and ... visualization tools and distributive control systems is a plus. + Knowledge of food GMP -s a plus. + Specific knowledge of Lean Manufacturing, Six Sigma, and TPM… more
- Terumo Medical Corporation (Somerset, NJ)
- …with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and EN46000. + Strong verbal and written communication skills ... **Qualifications/ Background Experiences** + Requires a BS Degree in Business Administration, Supply Chain Management, Finance, Economics, or similar. + Specialized training or Technical certifications a plus (ex. APICS) + 5 years of experience in Supply… more
- Catalent Pharma Solutions (Bridgewater, NJ)
- …standards: FDA , Good Engineering Practice (GEP), Good Manufacturing Procedures ( GMP ) and Good Documentation Procedures (GDP). + Demonstrated problem solving and ... bias for action skill set. Demonstrated ability to define and execute a strategy while concurrently delivering to metrics and driving a culture change. + Excellent verbal and written communication skills are essential. Strong attention to detail, people… more
- Integra LifeSciences (Plainsboro, NJ)
- …of critical analytical and process instrumentation and control loops used in GMP processes at the Integra Collagen Manufacturing Center (CMC). The Sr. Analytical ... military experience equivalent. + 3+ years calibration maintenance experience in FDA -regulated environment is preferable. + Knowledgeable in 6S execution in all… more