- AUROBINDO (Durham, NC)
- …in engineering/Chemistry/Scientific field RequiredMinimum 3 years experience in an analytical role, technical review role, or quality assurance role with ... an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control ...Required- Minimum 3 years experience in an analytical role, technical review role, or quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … quality counterparts that include Manufacturing Operations, Engineering and Validation, Quality Control , Operations Technical Support, and Quality ... and collaborative.Proficient in data collection and analysisAbility to critically review investigations to guide investigators and quality leaders… more
- Merck & Co. (Durham, NC)
- …product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Specialist ... SAP, Veeva and/or GLIMS.Experience in deviation management with focus on quality review and approval.Experience in Aseptic processing, aseptic observations,… more
- Merck & Co. (Durham, NC)
- …drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. - The Quality Assurance ... of GMP documentation such as IQ, OQ and other technical documents to meet schedule milestones. Provide QA shop...and/or GLIMS. Experience in deviation management with focus on quality review and approval. Experience in Aseptic… more
- BioAgilytix (Durham, NC)
- …here at BioAgilytix.Essential ResponsibilitiesPerform Quality Control (QC) technical , scientific, and compliance review of data and documentation ... be a critical part of our beginning-to-end client data quality processes. Through your technical reviews of...with attention to detail and minimal oversightAbility to perform technical review of data following GxP regulations… more
- Merck & Co. (Durham, NC)
- …active ingredient, finished product, and laboratory testing for the BCG vaccine.The Specialist, Quality Control participates in a team of analysts in the ... energize individuals at all levels in the organization FUNCTIONAL EXPERTISE: The Specialist, Quality Control will be responsible for activities that support cGMP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team setting with Quality , Manufacturing Operations, Facilities & Engineering Quality Control , Operations Technical Support, Supply Chain and ... other departments or outside contractors/vendors to complete tasksSupports and/or owns technical and quality investigations, CAPAs and correctionsDevelops and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Operations, Regulatory, Quality Assurance, Finance, R&D, Project Management and Quality Control departments to complete the technology transfer for ... those standards for all staff members, to include preparing and conducting performance evaluations. Review and ensure the reliability of technical data related to… more
- Twist BioScience (South San Francisco, CA)
- … quality decision-making.Contribute to the development and implementation of quality control procedures.Participate in product release activities, including ... up-to-date on the latest cGMP regulations and quality engineering practices.Provide quality support to quality control , field application scientists, and… more
- Merck & Co. (Durham, NC)
- …Other company sites, CMC-Reg, Procurement, Planning, Quality CoE, etcAuthor, review , and/or edit technical documents to support regulatory filings including ... technical /process issues, strategic projects, deviation management, change management, quality risk management, licensure and filing project management, and human… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …individual will need to build strong partnerships with Engineering and Facilities, Manufacturing, Quality Control and Quality Operations to drive continuous ... that all asset qualification activities are properly supporting for manufacturing, quality control , supply operations and for the site's requirement.Drive… more
- Novo Nordisk Inc. (Boulder, CO)
- …how early phase development transitions into commercial manufacturing Support the authoring and review of technical reports and protocols in support of cGMP ... cGMP batch documentation that ensures manufacturing can achieve the intended process control strategies. Review and approve change controls, in-process … more
- Merck & Co. (Rahway, NJ)
- …post-launch support.Ensure commercialization program meet requirements related to science, quality , reliability, schedule, and cost.Provide mentorship, technical ... Division, the Sterile Drug Product Commercialization (SDPC) group provides the technical process leadership and laboratory capabilities for late stage and commercial… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with responsibilities for providing quality oversight over the site Quality Control laboratories responsible for testing of pre-clinical, clinical, and ... method transfer protocols, completed assay data and reports primarily for the quality control laboratories.Key Responsibilities Be responsible for providing … more
- Formation Bio (New York, NY)
- …the PositionWe are seeking a highly motivated and detail-oriented Analytical Development and Quality Control biologics expert to join our CMC team. The ideal ... development and manufacturing organizations (CDMOs) in close collaboration with Quality and Regulatory colleagues.Responsibilities: Provide analytical development technical… more
- Aequor (Framingham, MA)
- … control , cost effective, and continuously improved. Provide collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause ... technical /scientific support, expertise, and guidance to manufacturing and quality . Ensure a solid understanding of engineering principles and theories in… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Engineer will be responsible for installing, modifying, and servicing process control systems throughout the facility as well as providing electrical engineering ... and maintenance by driving continuous improvement in the automation and control of the manufacturing processes as well as providing electrical engineering.… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Summary:Controls Engineer is responsible for installing, modifying, and servicing process control systems throughout the facility as well as providing engineering ... and maintenance by driving continuous improvement in the automation and control of the manufacturing processes as well as providing electrical engineering.… more
- Aequor (Thousand Oaks, CA)
- …Training and/or demonstrated experience in manufacturing systemsCompetencies Knowledge and Technical Expertise Understand basics of quality systems and ... and regional operations lead roles. Responsibilities Include: Demand Consolidation Review aggregate unit forecasts in preparation for demand consensus meetings… more
- Tris Pharma (Monmouth Junction, NJ)
- …+ QBD principles in guiding pharm development + identifying critical quality attributes (CQA), critical material attributes (CMA), critical process parameters (CPP) ... + control strategies. Use problem solving tools to troubleshoot. Design...development lab areas, equip, + instruments properly maintained. Support review of qualification docs for process equip. Support tech… more
