- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Quality Engineer is responsible for ensuring cGMP compliance of all relevant FDA regulations and internal procedures/specifications relating ... cGMP requirements. In this role, they assure the company's Quality Plan is fully implemented by the engineering department...to document decisions and rationale. Data Integrity - assure GMP data captured and managed by engineering are handled,… more
- Insmed Incorporated (San Diego, CA)
- …fast paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management ... for the QC stability and sample management operations in support of routine GMP operations at Insmed Gene Therapy. The ideal candidate will have commercial … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that CMC documentation is complete, well organized, scientifically sound, of a high quality , aligned with the current regulations, and presented in a manner that ... facilitates Health Authority reviews.- Supports company`s GMP Change Management Program. Evaluates CMC changes for portfolio biologics and determines filing… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This position has QA signature authority… more
- Aequor (Thousand Oaks, CA)
- …to have process/utility Engineering technical experience and not only be quality background driven. This engineering position supports projects that associated with ... safety, and 's Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state, equipment &… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …therapy process development, manufacturing science, analytical development, and familiarity with GMP / FDA /ICH .Key Responsibilities Subject matter expert of QC ... result in paradigm shift in throughput and capacity Maintain current awareness of GMP /GLP/GCP/GDP, ICH, USP, and FDA guidelines, industry standards, and trends… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. - - Position Description - This is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the 8 years must include MSAT experience.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceuticals. Experience in ... seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …practicesStrongly interface with Operations Department and other supporting groups (Engineering, Quality Control, Quality Assurance and other as applicable) to ... absence.Assist management during internal and external regulatory audits (including FDA , EMEA)Establish key stakeholder relationships with internal and external… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …seeking a QA Investigations Lead (1st or 2nd shifts) as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Investigations Lead has the ... responsibilities for providing quality oversight over the production of a personalized cell...support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …training is completed in compliance with all applicable procedures, standards and GMP regulations.Work with Process Development team, Quality and Operations ... is seeking a QC Technical Traineras part of the Quality team based in Raritan, NJ. Role OverviewThe QC...for clinical trials and commercial operations in a controlled GMP environment. This position is primarily a M-F schedule,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …testing is completed in compliance with all applicable procedures, standards and GMP regulationsWork with Process Development team, Quality and Operations ... Sr. QC Analyst (Third Shift) as part of the Quality team based in Raritan, NJ. Role OverviewThe Sr....for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities Be responsible for the completion of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …key player in the Deviation Response Team team and a champion for quality priority principles and compliance within the organization.This role is a full-time onsite ... during regulatory inspection through close collaboration with Operations and Quality teamsLead cross-functional investigation teams to identify root cause, evaluate… more
- Merck & Co. (Rahway, NJ)
- …team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of ... is expected, as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes managing Quality Leaders and approving critical ... Biotech is seeking QA Investigations Supervisor (2nd shift) as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Investigations Supervisor has the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …clinical quality , or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceutical. Experience in ... seeking QA Lab Oversight Specialist as part of the Quality team based in Raritan. Role OverviewThe QA Lab...is an exempt level position with responsibilities for providing quality oversight over the site Quality Control… more
- Novo Nordisk Inc. (Boulder, CO)
- …management experience A deep understanding of and ability to apply of GMP /ICH/ FDA regulations to process development strategies for Oligonucleotide based drugs ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is seeking a QC Microbiology Specialist, Lentivirus CAR-T Manufacturing as part of the Quality team based in Raritan, NJ. The current openings are on the third ... support clinical trials and commercial operations in a controlled GMP environment.Major ResponsibilitiesResponsible for performing routine EM sampling, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking a Supervisor, QC Micro as part of the Quality Control team based in Raritan, NJ. Role OverviewThe QC Microbiology Supervisor, CAR-T ... products for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities Responsible for performing routine EM sampling, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma.Legend Biotech is seeking a QC Data Revieweras part of the Quality team based in Raritan, NJ. Role OverviewThe QC Data Reviewer is an exempt ... level position responsible for reviewing all data produced by the Quality Control Lab during In-Process and release Drug Product QC Testing, related to the… more
