- 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
- Endo International (Horsham, PA)
- …Develop and implement solutions to validation related discrepancies and deviations + Ensure compliance to data integrity requirements in a GMP environment + ... support for issue resolution. Additionally, this role would be the Subject Matter Expert for Data Integrity for the Quality Control department. The role is… 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
- Merck (West Point, PA)
- …chain metrics and/or participate in critical non-pipeline activities as a subject matter expert in a particular area of expertise. + Mentors new team members and ... in project / portfolio management. + Knowledge of Good Manufacturing Practices ( GMP ) and Good Clinical Practices (GCP) is highly desirable. **Preferred Experience… more
- Kelly Services (West Point, PA)
- …in support of sampling and material transfer. Maintain training and compliance with site safety and quality requirements. Selected Responsibilities: + Print, ... for clinical product labels. + Process labeling/packaging batch paperwork according to GMP /GDP. + Verify before use that equipment calibration date has not been… more
- Kelly Services (West Point, PA)
- …tasks related to clinical label printing production. Maintain training and compliance with site safety and quality requirements. Selected Responsibilities: * ... for clinical product labels. * Process labeling/packaging batch paperwork according to GMP /GDP. * Verifies before use that equipment calibration date has not been… 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
- Insight Global (Malvern, PA)
- …including CAR-T. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They ... with limited oversight -Act as a peer subject matter expert in assessing talent by participating in panel interviews.... Skills and Requirements -Minimum one year of relevant GMP work experience in a lab setting -Bachelor degree… 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
- Merck (West Point, PA)
- …team as an Associate Director, Maintenance & Utilities. As a subject matter expert in an engineering field critical to packaging operations, you will be responsible ... State and Local code requirements for quality, good manufacturing practices ( GMP ), equal employment opportunity, finances, labor, employee, environment and safety. +… 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
- WuXi AppTec (Philadelphia, PA)
- …concepts + Oversees and monitors overall performance of aseptic technique ensuring compliance with standards + Has performed aseptic technique, is able to identify ... feedback for facility fit + Helps with application of GMP concepts and is able to recommend and identify...proficiency and able to act as an subject matter expert (SME) and/or Super user on multiple systems +… more
- Merck (Upper Gwynedd, PA)
- …seeking a highly motivated individual to serve as a leading scientific expert providing guidance, recommendations and judgment for strategic technical issues and ... The Associate Director is expected to serve as a leading scientific expert providing strategic guidance, recommendations and judgment for technical issues and… more
- Merck (West Point, PA)
- …develop and maintain global training materials, and be a subject matter expert on information systems supporting change control. **Primary activities include, but ... A robust and sustainable change management process is critical to ensure compliance with regulatory dossiers and compliant supply. The selected candidate will work… more