- Actalent (Shawnee Mission, KS)
- …Document Control Specialist Key Responsibilities: + Maintain document control for GMP documents, ensuring accuracy and compliance with paper-based data integrity ... raw data form sheets in a controlled manner. + Organize and manage GMP documentation, including filing, tracking, and retrieving completed records such as batch… more
- Eurofins US Network (Lancaster, PA)
- …of biological substances and products. **Job Description** **Role Overview** The GMP Testing Project Manager is responsible for planning, coordinating, and ... overseeing Good Manufacturing Practice ( GMP )-compliant testing projects within a regulated laboratory environment. This role ensures timely delivery of testing… more
- Eurofins US Network (Lancaster, PA)
- …quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations. + Review simple and complex routine and non-routine ... analytical procedures; ensure all work is performed according to GLP/ GMP requirements and apply GLP/ GMP in all areas of responsibility + Experience in a… more
- System One (Indianapolis, IN)
- …organization provides central execution support in onboarding suppliers, materials, and GMP service providers in a timely manner to support project timelines ... focus is to provide a globally holistic process in which GMP supplier and GMP service provider's Supplier Quality Management activities are globally consistent,… more
- 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
- 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
- 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