- Merck (West Point, PA)
- …and perform various automation activities supporting pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines and therapeutic proteins) clinical ... the pilot plant's reliability and increase efficiencies + Author and review GMP change controls, test protocols, SDLC documentation, SOP's, safety reviews, deviation… more
- WuXi AppTec (Middletown, DE)
- …operate efficiently, meet testing timelines, and remain in full compliance with GMP and regulatory requirements. The QC Operation Specialist will be a key ... login, storage, and distribution processes, ensuring traceability, chain-of-custody, and GMP compliance. * Oversee control, qualification, and inventory of reference… more
- Fujifilm (Thousand Oaks, CA)
- …for guiding the Manufacturing Team in the execution of clinical and commercial GMP cell therapy activities. These include media preparation, master cell banks, viral ... activities in an aseptic environment, ensuring adherence to schedules and GMP compliance + Operations Management: Assist in daily manufacturing operations, identify… more
- Merck (Rahway, NJ)
- …both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, ... trialing new automation strategies, and implementing them in the GMP areas + Support capital projects, work to design,...to design, install, and qualify new equipment to support GMP clinical production. Write, review or execute test documents.… more
- Eurofins US Network (Boston, MA)
- …The successful candidate will be responsible for daily R&D and GMP gene-editing operations, including iPSC culture, gene editing platform development and ... CRISPR-based iPSC gene editing and iPSC cell line generation to enable GMP readiness. + Develop and optimize gene-editing workflows, including gRNA design, RNP… more
- Actalent (Louisville, CO)
- …to own and execute quality event investigations within a dynamic GMP manufacturing environment. The role involves investigating manufacturing-related quality events ... change control records and manage continuous improvement initiatives to enhance GMP efficiency. This position requires the ability to independently track, manage,… more
- ThermoFisher Scientific (Franklin, MA)
- …**Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards **Job Description** **Location/Division Specific Information** This ... Impactful Work:** The QA/QC Specialist is responsible for driving the day-to-day GMP Quality Control and Quality Assurance activities for the Franklin MA Commercial… more
- US Tech Solutions (Easton, PA)
- **Shift** : 8:00 AM to 5:00 PM, Monday-Friday. Onsite at a third-party GMP -compliant warehouse in PA. **Job Description:** + The ideal candidate will have 5+ years ... of QA experience specifically involving raw materials in a GMP -regulated environment such as pharmaceutical, biotech, or other life sciences industries. + A… more
- ThermoFisher Scientific (Plainville, MA)
- …and drug product technology transfer activities. + Lead technology transfer to GMP from clients or the internal development team, including process/facility gap ... assessments and drafting/reviewing GMP documents (batch records, tech transfer protocols, sampling plans). + Lead the downstream tech transfer team; build and… more
- Herbalife (Winston Salem, NC)
- …+ Assist production staff with the correct understanding and implementation of GMP procedures and company policy + Document and investigate (as appropriate) foreign ... rejected, hold, etc. + Document quality-related incidents using appropriate GMP documentation (eg, nonconforming materials report, unplanned deviation report,… more
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