- Cardinal Health (Chicopee, MA)
- …to ensuring equipment reliability, reducing downtime, and maintaining compliance with FDA , ISO, and DEP standards and regulations. **Responsibilities:** + Perform ... equipment compliance and readiness. + Ensure all maintenance activities comply with GMP, FDA , and ISO 13485 standards. + Assist and maintain spare parts inventories… more
- Emmi Roth (Stoughton, WI)
- …Essential Duties & Responsibilities* Ensures compliance with government regulations ( FDA , EPA, etc.), customer requirements and necessary certification bodies (ie ... safety policies and all government food safety and sanitation regulations (ex. FDA , HACCP, GMP, OSHA, GFSI)* Conduct regular audits of production processes,… more
- Kuehne+Nagel (Cranbury, NJ)
- …with full lot genealogy. + Author SOPs and training compliant with FDA cosmetics guidance and ISO 22716 for storage hygiene, documentation, and traceability. ... experience handling cosmetics/CPG with lot & expiry controls and SOPs aligned to FDA /ISO 22716. "The right candidate will have a continuous improvement mindset and a… more
- Endo International (Rochester, MI)
- …a body of information required for the job_ _e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc._ + Basic understanding of ... state, federal and local standards and regulations, eg, cGMP, OSHA, EEOC, EPA, FDA and DEA. Skills & Abilities _Often referred to as "competencies", leadership… more
- Hologic (Marlborough, MA)
- …engineering, we encourage you to apply! **Knowledge:** + Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU ... year** with a PhD in a related field. + Experience in an FDA -regulated industry preferred. + Hands-on experience in root cause analysis, complaint investigations,… more
- Vitality Works Inc (Albuquerque, NM)
- …industry experience in pharmaceutical or similar industry or work in a FDA /ISO highly regulated environment strongly preferred. + Working knowledge of multiple human ... vitamin and nutraceutical supplements to help people get and stay well. While the FDA defines minimum quality, we strive for the highest level of quality. Vitality… more
- Vitality Works Inc (Albuquerque, NM)
- …vitamin and nutraceutical supplements to help people get and stay well. While the FDA defines minimum quality, we strive for the highest level of quality. Vitality ... team + Stay abreast of industry news, trade shows, periodicals, trends, FDA communications and industry regulations + Work with other departments in communicating… more
- Catalent Pharma Solutions (Harmans, MD)
- …viral vectors, next-generation vaccines, and oncolytic viruses. Our FDA -licensed, state-of-the-art Gene Therapy manufacturing campus in Harmans/BWI features ... installing and placing new equipment into operations. + Ensures compliance to FDA regulations and follows GAMP in task execution, including change control and… more
- Astrix Technology (Los Angeles, CA)
- …2 years management experience. Experience drafting & rewriting SOPs, audits, FDA filings/docs, CAPAs, change controls, batch records, documentation. Knowledge of ISO ... 22716 & FDA regulations INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race,… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …+ Provide critical inputs and requirements for product stability and FDA and other agency submissions. Qualification of primary and secondary/tertiary packaging ... (cartons, labels, shippers, displays). + Experience with cGMP's, all applicable FDA guidelines and Quality Systems. Prefer additional understanding of ISO, USP,… more