- Insight Global (Gaithersburg, MD)
- …seismic/wind design, floor loading, vibration control) in line with company requirements, GMP , and safety standards. * Technical governance to the project delivery ... with company Global Engineering Standards, local/national codes, fire/life safety, SHE, GMP /GEP, and CPDP stage-gated assurance. * Technical support to the receiving… more
- BeOne Medicines (Pennington, NJ)
- **General Description:** Perform QC Chemistry laboratory activities to support GMP manufacturing, testing and release of materials, intermediates and finished ... operations. + Review, interpret, and report analytical data in accordance with GMP regulations and internal procedures. + Ensure appropriate investigation of OOS… more
- Insight Global (Gaithersburg, MD)
- …that meet Global Engineering, Quality, and SHE requirements, supporting GMP manufacturing environments. Key Responsibilities Include: - Technical Leadership: Define ... changes, pressure cascades, temperature/RH, filtration, ventilation/exhaust, utility quality). Translate GMP and operational needs into specs, drawings, and control… more
- PCI Pharma Services (Bedford, NH)
- …Visual Inspection activities for clinical and commercial drug product in a GMP facility. The work scope includes on-the-floor Quality oversight of manufacturing ... aseptic processes, performing AQL visual inspection of finished drug product vials, GMP documentation and Batch Record review, line clear and product changeover… more
- 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
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