- 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
- 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
- Actalent (Parsippany, NJ)
- …handle process and equipment deviations on the floor as subject matter expert . Assist Production Operators, as needed, with prep work, autoclave, process components ... development of SOPs and skills training materials to ensure compliance with all company SOPs, policies, cGMPs and applicable...and equipment deviations on the floor as subject matter expert . + Assist Production Operators, as needed, with prep… 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
- 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
- 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
- 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
- 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
- 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
- Actalent (Parsippany, NJ)
- …documents including SOPs, testing protocols, and new testing methodologies. + Assist with GMP Compliance program in the QC Laboratory, including management of ... Job Title: Quality Control (QC) Compliance SpecialistJob Description The QC Compliance ...and troubleshoot findings. + Act as a subject matter expert in one or more fields of microbiology (eg,… 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)
- …drug product design from the bench top to the Good Manufacturing Practice ( GMP ) manufacturing facilities, our Scientists use cutting edge science to transform drug ... drug delivery technologies + Is a recognized subject matter expert in at least one area of drug delivery...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los… more
- Integra LifeSciences (Plainsboro, NJ)
- …in the analytical test methods and is responsible for operating in compliance with all applicable procedures and policies. **ESSENTIAL DUTIES AND RESPONSIBILITIES** ... must be able to perform each essential duty satisfactorily. + Ensure compliance with all company policies and procedures and appropriate regulations, including FDA… more
- Merck (Rahway, NJ)
- …clinical supply planning group (eg, process improvement initiatives, subject matter expert roles, cross functional projects, etc.) + Demonstrates high capability to ... in project / portfolio management. + Knowledge of Good Manufacturing Practices ( GMP ) and Good Clinical Practices (GCP) is highly desirable. **Preferred Experience… more
- Merck (Rahway, NJ)
- …are not limited to, the following:** + Act as a global Subject Matter Expert (SME) for primary packaging and device components; this expertise must span the ... 5 years in pharmaceutical manufacturing or technical support roles related to GMP manufacturing of Large Molecule and Sterile Small Molecule products + Strong… more