- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ. Role ... a controlled cGMP cleanroom environment.Create, review and approve relevant QC documents, logbooks, SOP's and WI's.Ensure microbiological control strategy is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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 ... Control Lab during In-Process and release Drug Product QC Testing, related to the manufacturing of...for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities Perform peer review /approval of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsibilities for supervising the operation and workflow of the quality control laboratories in support of cell therapy manufacturing . This includes ... required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control , quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within a biological and/or pharmaceutical industry is required Experience in a Quality Control setting is preferred.Experience with biosafety cabinets is ... the treatment of multiple myeloma.Legend Biotech is seeking a QC Technical Traineras part of the Quality ... systems, and cGMP requirements.Support in daily completion of QC testing related to the manufacturing of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as part of the Quality team based in Raritan, NJ. Role OverviewThe QC Analyst, CAR-T Manufacturing is an exempt level position with responsibilities for ... performing QC testing related to the manufacturing of...a biological and/or pharmaceutical industry is requiredExperience in a Quality Control setting is preferredExperience with aseptic… 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 ... cGMP facility to manufacture products.Create, review and approve relevant QC documents, SOP's and WI's.Ensure microbiological control strategy is consistent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma.Legend Biotech is seeking a QC Microbiology Specialist, Lentivirus CAR-T Manufacturing as part of the Quality team based in Raritan, NJ. The ... Development team, Quality and Operations organization to successfully transfer LVV manufacturing process to cGMP facilityCreate, review and approve relevant … more
- Insmed Incorporated (San Diego, CA)
- …Change Control and CAPA/Effectiveness Checks. Provide expert QA review , collaboration, and direction for laboratory investigations.Apply Quality Risk ... QA oversight of Insmed Gene Therapy (GTx) analytical laboratories, review and approval of GMP analytical records....analytical records. Will also provide QA support for GTx Quality Control laboratories. This position is onsite/hybrid… more
- Insmed Incorporated (San Diego, CA)
- …collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management Manager, ... daily/weekly/monthly activities of staff and operational oversight of group, data review , schedule, and training.Potentially oversee QC technicians and directly… more
- Merck & Co. (Rahway, NJ)
- …knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and regulatory requirements; ... of the organization and participates in regulatory and other quality and compliance report-outs; review audit outcomes...Systems, Quality Assurance and Quality Control including solid knowledge of global GMP … more
- Novo Nordisk Inc. (West Lebanon, IN)
- …support records to certify compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues ... Are you ready to realize your potential? The Position This position will review manufacturing and support documentation and records to certify compliance with… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …regular internal audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality Control to resolve open issues resulting from ... and other ancillary support records. Will be a QA presence on the manufacturing floor. Relationships Quality Assurance. Essential Functions Reviews all … more
- Insmed Incorporated (San Diego, CA)
- …collaboration with both internal and external drug substance analytical, quality control , quality assurance, and manufacturing teams.Exercise judgment in ... participate in the process execution within a cGMP manufacturing environment. Review batch records, SOPs, raw material specifications, GMP protocols, and… more
- ThermoFisher Scientific (Worcester, MA)
- …full-time benefits. **Key responsibilities:** The QC Data Reviewer supports the data review team within a fast paced GMP environment in support of one or ... Schedule** Second Shift (Afternoons) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards **Job Description** At… more
- Kelly Services (Oklahoma City, OK)
- …high- quality biopharmaceutical products. **RESPONSIBILITIES:** + Execute and monitor GMP manufacturing processes for cell culture-based production, ensuring ... ** GMP Manufacturing Associate - Cell Culture...attention to detail. + Collaborate with cross-functional teams, including Quality Control and Quality Assurance,… more
- Fujifilm (College Station, TX)
- …consumables list for new client programs + Work with Supply Chain, Process Development, Manufacturing Operations, Quality Control , and Quality Assurance ... Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor and on time starts...forms for new equipment and route them in document control system + Generate WR for changes / service… more
- Lilly (Lebanon, IN)
- …molecules. This position will interact with engineering, manufacturing , validation, quality assurance, quality control , development, and regulatory ... to build the processes and facility to enable a successful startup into GMP manufacturing operations. **Main Purpose and Objectives:** This position is… more
- Catalent Pharma Solutions (Harmans, MD)
- …of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing . Lifting to 40 lbs., unassisted may be required at times. ... Associate II** is responsible for supporting the overall GMP upstream or downstream manufacturing process, through...oral communication skills. + Possesses a basic knowledge of non- manufacturing functions such as QC , Regulatory, QA,… more
- GE HealthCare (Madison, WI)
- …and validate analytical instruments and software accordingly to current Good Manufacturing Practices ( GMP ) requirements + Ensure the technical support ... **Job Description Summary** **Job Description** Role Summary- A manufacturing Engineering Specialist is in charge of working...instruments and contribute to keep the instruments in the QC Dept in required condition at any time +… more
- ThermoFisher Scientific (West Hills, CA)
- **Work Schedule** First Shift (Days) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Some degree of PPE ... lab coat, ear plugs etc.) **Job Description** Position Summary: The Scientist II, Manufacturing Sciences will serve as the lead for projects related to development… more
