- Merck (Trenton, NJ)
- **Job Description** The Director of GMP Compliance will be a part of the Compliance Support and Remediation team within our company's Global Quality ... SMEs. **Job Function:** + serve as a subject matter expert for good manufacturing practices ( GMP ) for...authority/board of health as an inspector, investigator, product reviewer, compliance officer, or other GMP /regulatory role +… more
- Boehringer Ingelheim (North Brunswick, NJ)
- **Description** + Be the "go to" technical expert for Global MSAT and Operations leadership for BIAH products and processes for analysis and guidance throughout ... MO or Duluth, GA.** **Duties & Responsibilities** + Be the "go to" technical expert for Global MSAT and Operations leadership for BIAH products and processes for… more
- Promotion In Motion (Somerset, NJ)
- …+ Manages annual EHS budget and prepares forecasts expenditures. + Follow PIM Brands GMP rules. + Report food safety and quality issues to Plant management and SQFP ... + Monitor associates for adherence to GMP 's. + Provide associates with the tools, programs, policies...minimize safety and occupational health hazards. + Support SQF/NSF compliance through active participation in internal audits and factory… more
- Fujifilm (Trenton, NJ)
- …regard to biologically contaminated solid waste materials, serve as the subject matter expert for laboratory safety, be a resource to EHS teams for facility safety ... audits, and represent FDB as a biosafety subject matter expert . This role will have 7-10 direct and indirect...certifications, and related work experience. + Strong understanding of GMP principals and working within a quality centric organization… more
- ManpowerGroup (Princeton, NJ)
- …technical support to Princeton, NJ Facility. Manufacturing processes in a GMP environment. Technical support includes troubleshooting process and equipment related ... manufacturing process. Functions as a technology and process subject matter expert . Provides on-the-floor and on-site technical support to manufacturing when… more
- Novo Nordisk (Plainsboro, NJ)
- …needs + Product Quality: + Oversees the implementation of procedures to ensure compliance with Good Manufacturing Practice ( GMP ) with respect to technical ... responsible person, the head of Patient Safety will act as the safety expert to establish and maintain processes, procedures and controls to ensure compliance… more
- Catalent Pharma Solutions (Somerset, NJ)
- …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent employee. **This ... is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and Catalent employee.** **The… more
- ManpowerGroup (Franklin Twp, NJ)
- …analytical testing, adhering to standard operating procedures (SOPs), and ensuring compliance with regulatory guidelines such as cGMP and ICH regulations. The ... Fischer, following standard operating procedures (SOPs) and good manufacturing practices ( GMP ). + Review and interpret analytical data, investigate any deviations or… more
- AbbVie (Branchburg, NJ)
- …the day. + Provides on the floor training to support formalized technical and GMP training. Check that operator training files match and support the processes they ... out. + Monitors operator training files and work with compliance specialist to keep files up to date. +...to date. + Works with QA and Subject Matter Expert (Tech Ops or Process Sciences) to resolve exceptions.… more
- BeiGene (Hopewell, NJ)
- …Release Key processes and QA objectives, whilst adhering to regulatory compliance and achieving commercial success. Assists associates with deviation management and ... as ensuring the departmental performance against goals. + Site expert on ERP software such as SAP + Reviews...all Quality Assurance floor activities and systems to ensure compliance with FDA/EU regulation, covering cGMP for commercial medicinal… more
- BeiGene (Hopewell, NJ)
- …Batch Release Key processes and QA objectives, whilst adhering to regulatory compliance and achieving commercial success. Assists shop floor Mfg. associates with ... monitoring all Quality Assurance shop floor and batch systems to ensure compliance with FDA/EU regulation, covering cGMP for commercial medicinal products and… more
- Kelly Services (Princeton, NJ)
- …**Responsibilities** + Facilitation of quality system document control activities in compliance with US and International requirements as defined in FDA Regulations, ... the changes are processed in the Electronic Document Management system in compliance with internal procedural requirements. + Collaborate with the other team members… more
- Integra LifeSciences (Princeton, NJ)
- …support development and sustaining/remediation projects. + Ensure that all projects are in compliance with GMP , QSR, ISO or other applicable requirements. + ... audits and internal audits as an NPD and/or Sustaining/Remediation subject matter expert . + Writing & coordinating efforts for the development and implementation of… more