- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of GMP Compliance will be a part of the Compliance Support and Remediation team within our company's Global Quality Compliance ... Health operating units and requires extensive collaboration with manufacturing sites and global GMP SMEs.-Job Function:serve as a subject matter expert for good… more
- Merck & Co. (Rahway, NJ)
- …communication. Defining and implementing operational control strategies to ensure efficient GMP processes while maintaining high-level of compliance and ... portfolio. In this role, you will work with the GMP Analytical and Raw Materials teams on strategies associated...the AR&D organization in aspects of quality control and compliance . Your main responsibilities will include: - Strategy and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This role includes supervision of QA shop floor personnel as well ... personnel, Product Development, andQuality/Manufacturing personnel.Independently makes appropriate and compliant GMP decisions.Independently resolves problems through the use of quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety 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
- Merck (Rahway, 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 (New 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
- Bristol Myers Squibb (Summit, NJ)
- …Senior Managers, Managers, Team Leads and Material Handlers that interface with GMP cleaning and EM sampling partners responsible for all processes associated with ... GMP cleaning & EM Sampling within CAR T clinical...(future 12hr/7d Operation). This position assures individual and group compliance with all FDA, DEA, DOT, ISBT, CTPAT, OSHA,… 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
- Bristol Myers Squibb (Summit, NJ)
- …Sample Storage in Cryotanks), Patient Materials Mgmt (APH receipt and DP Packout), GMP Cleaning and EM Sampling within CAR T clinical and commercial operations in ... all tasks of MSS organization ranging for EM Sampling, GMP Cleaning, APH receipt, DP Packout, sample retrieval, sample...(future 12hr/7d Operation). The position assures individual and group compliance with all FDA, DEA, DOT, ISBT, CTPAT, OSHA,… more
- Bristol Myers Squibb (Summit, NJ)
- …Cell Therapy manufacturing processes, maintaining a culture of safety, compliance , innovation, and Continuous Improvement within the Manufacturing Operations ... adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion ** GMP ** + Is accountable to ensure their Manufacturing Managers and their WCT… more
- Insight Global (Rahway, NJ)
- …support consistent documentation and process standardization across the organization. Ensure compliance with GMP , FDA, and other regulatory standards throughout ... We are seeking a highly skilled and motivated Process Engineer / Subject Matter Expert (SME) with 2+ years of Drug Substance / Drug Product experience in… more
- Merck (Rahway, NJ)
- …+ Defining and implementing operational control strategies to ensure efficient GMP processes while maintaining high-level of compliance and scientific ... our small molecule portfolio. In this role, you will work with the GMP Analytical and Raw Materials teams on strategies associated with Operational Excellence. The… 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
- Bristol Myers Squibb (Summit, NJ)
- …guidelines. **Knowledge & Skills:** + Must have advanced knowledge and experience with GMP , Quality, and compliance . + Able to write and review technical ... + Responsible for ensuring accurate printed information on labels in compliance with health authority requirements. + Coordinates with production teams to… more
- Merck (Rahway, NJ)
- …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
- 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
- Bristol Myers Squibb (Summit, NJ)
- …and multiple shifts (future 12hr/7d Operation). The position assures individual and group compliance with all FDA, DEA, DOT, ISBT, CTPAT, OSHA, VAWD, cGMPs and ... procedures, and corporate policies while maintaining a culture of safety, compliance , innovation, and Continuous Improvement. **Shifts Available:** Monday - Friday,… more
- Bristol Myers Squibb (Summit, NJ)
- …and multiple shifts (future 12hr/7d Operation). The position assures individual and group compliance with all FDA, DEA, DOT, ISBT, CTPAT, OSHA, VAWD, cGMPs and ... procedures, and corporate policies while maintaining a culture of safety, compliance , innovation, and Continuous Improvement. **Shifts Available:** Monday - Friday,… more
- Merck (Rahway, NJ)
- …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
