- Novo Nordisk Inc. (Boulder, CO)
- …worlds to develop new medicines for patients. The Position Novo Nordisk is seeking a Quality Control Manager to support the successful start-up of the Quality ... of US FDA, ICH Q7, & ISO regulations, guidelines, and applications of cGMP 's within Quality Control laboratory Demonstrated knowledge of pharmaceutical industry… more
- Novo Nordisk Inc. (Boulder, CO)
- …us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new ... the authoring and review of technical reports and protocols in support of cGMP activities. Serve as the technical expert supporting the development of process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking an Investigations Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Manager of CAR-T ... implement process improvements related to investigations cycle time, closures, quality , and compliance.Develop strategies to increase investigations output while… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …support of commercialization. Serve as a technical resource to improve product quality , reliability, and process capability. Support manufacturing to satisfy the ... quality and process validation requirements for existing products. Participate...and existing processes (including Equipment IOPQ, Process, etc.) against cGMP and requirements for validationDevelop and implement strategies for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …compliance.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Critically support investigations and reports, ... manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell therapy.Knowledge of cGMP regulations and FDA/EU… more
- Merck & Co. (Durham, NC)
- …Ensure individually assigned aspects of the project proceed in compliance with cGMP , regulations, and our Company's Quality Management System. Provide QA ... product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. - The Quality Assurance Specialist will… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP , USP, and CDR rules, and guidelines), and ensure compliance with testing SOPs ... performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate… more
- Houston Methodist (Houston, TX)
- …and prioritize daily tasks **GROWTH/INNOVATION ESSENTIAL FUNCTIONS** + Participates with the Quality Assurance Manager and/or cGMP Core Director in ... experience in organic synthetic chemistry; + Knowledge in basic analytical chemistry, including High Performance Liquid Chromatography (HPLC); +...defining quality policies. + Assists Quality Assurance Manager , cGMP Core… more
- Honeywell (Baton Rouge, LA)
- The Quality Assurance (QA) Manager oversees, implements, and maintains cGMP compliant systems and activities. Incumbent is also responsible for evaluating ... maintenance of cGMP documentation for compliance with quality and regulatory standards. The GMP QA Manager...with disabilities to perform the essential functions. + Ensures cGMP analytical activities, such as analytical… more
- Fujifilm (Thousand Oaks, CA)
- …a culture that will fuel your passion, energy and drive - what we call Genki. The Manager Quality Control Analytical will manage a group of Quality ... and approve laboratory procedures, protocols and reports. + Support cGMP manufacture and supply of high- quality cell...+ Support cGMP manufacture and supply of high- quality cell therapy products. + Assess analytical … more
- Curia (Hopkinton, MA)
- SUPERVISOR, QUALITY CONTROL ANALYTICAL in Hopkinton, MA Build your future at Curia, where our work has the power to save lives. Curia is a global contract ... and ultimately to improve patients' lives. The Supervisor of Quality Control (QC) is responsible for oversight of the...Control (QC) is responsible for oversight of the QC Analytical unit, at the direction of the Manager… more
- LGC Group (Petaluma, CA)
- …the organization. The successful candidate will be detail-oriented, proficient in review of analytical data for quality control, educated in analytical ... with a broad suite of bioinformatics, biology, chemistry, manufacturing and analytical services that support discovery, pre-clinical and clinical trials and scale-up… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …QC - Chemicals, this role manages and provides leadership for the Analytical Chemistry Incoming Quality Control Team and ensures appropriate capabilities, ... and processes are developed, implemented, monitored and maintained. The QC Manager is tasked with oversight of sophisticated chemistry techniques, oversight and… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Group: AbbVie Analytical Research & Development ( Analytical R&D) is a global ... analytical scientific organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products. Our scope… more
- Sanofi Group (Ridgefield, NJ)
- …from infectious diseases and bring hope to patients and their families. **The Manager Quality Control** is responsible for technical management of personnel ... interpreting quality procedures and test methods. The manager Quality Control will substantially contribute to...degree in Life Sciences discipline and 4-year experience in CGMP lab Environment, and background in Analytical … more
- Bristol Myers Squibb (Devens, MA)
- …teams to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP . The Manager , Shop Floor Quality Assurance, Cell ... This is a key role on the Shop Floor Quality Assurance team. As Shift Manager for...QA on-the-floor systems and programs that enable the highest quality and the quickest delivery of QA cGMP… more
- Fujifilm (College Station, TX)
- …principles. + Strong analytical and problem-solving skills. + Certifications: Certified Quality Manager (CQM), Certified Quality Engineer (CQE) or ... instill a ' Quality Culture' by coaching on the application of CGMP Principles including the underlying rationale. + Collaborate with Business Process Owners and… more
- Vera Therapeutics (Brisbane, CA)
- …maintain regular contact with key stakeholders including Research, Clinical Pharm, Analytical Science, Drug product, Quality Assurance, Regulatory Affairs, ... represent CMC Process Development in project teams. * Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents. Qualifications: * PhD/MS… more
- CoreRx (Clearwater, FL)
- We are currently accepting applications for future Quality Control Chemists. WHY CORERX CoreRx, a dynamic pharmaceutical technology company that empowers its ... choosing CoreRx as your employer of choice. DESCRIPTION The Analytical Chemist II is an integral part of the...and wet chemistry testing as required in compliance with cGMP requirements, compendia standards, and internal procedures Ensures testing… more
- Vera Therapeutics (Brisbane, CA)
- …and maintain regular contact with key stakeholders including Drug Product, Analytical sciences, Quality Assurance, Regulatory Affairs, Supply chain, Finance, ... Title: Senior Manager , Process Development, Downstream Location: Brisbane, CA About...of CMC related regulatory submissions (eg, BLA) and associated quality documents. The candidate must have exceptional organizational and… more
