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We own and operate a GMP biologics manufacturing drug substance. Possess prior work experience in a GMP, biotechnology and/or FDA regulated environment. Ensure the efficient maintenance and reliable operation of the process, HVAC and utility equipment needed to support a GMP manufacturing facility including supporting site laboratories.
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Experience working with SOPs, GDP, GMP, CLIA, and the FDA. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. That’s how we tackle rare disease. By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s and.
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5+ years of Quality Assurance experience in a QSR (GMP), disposable medical device environment. Multiple subassemblies for various OUs including SH, CRM, CRDN, PVH, PV, NM, etc. Assist with protocol and implement process validation procedures in accordance with QSR, FDA and international guidelines.
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REMOTE WORK FROMHOME AVAILABLE The Job: Development of purification manufacturing processes meeting GMP manufacturing requirements. Demonstrated experience in a broad range of techniques in the area of protein purification and handling.
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Project delivery types include design/build, negotiated GMP, Lump Sum Bidding, and CM at Risk contracts. We are a General Contractor/Construction Manager that is established pursuing a variety of commercial and light industrial projects throughout the nation.
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Knowledge of industry regulations and standards, such as FDA and GMP. Bachelor's degree in a related field, such as quality management, food science, or engineering. Minimum of [5] years of experience in quality management within the co-manufacturing or food manufacturing industry.
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Als Mitarbeiter Qualittskontrolle Radiopharmazie untersttzt du das Manufacturing-Team in Braunschweig bei Durchfhrung von analytischen Prfungen an radioaktiven Pharmazeutika, Medizinprodukten, Rohmaterialien, Hilfsstoffen, Verbrauchsmaterialien undweiteren zur Produktion bentigten Equipments oder Materialien gem den Anforderungen von GMP / GLP zur Feststellung.
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VP Preconstruction - Construction Management - 100% Remote. We are seeking a VP of Preconstruction to work 100% remotely that will lead and manage all preconstruction service activities and personnel, and act as primary liaison for the preconstruction services group between the Business Developent and the Operations Group.
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2-3 years of experience working with analytical and biologic methodologies (chromatography, HPLC and ELISA in a regulated GMP/GLP Lab environment) HPLC, GC, KF, and UV/Vis. This position will also be working part of the time in the lab as the expert on HPLC and Empower in a GMP lab setting.
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E.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. Demonstrates the ability to conduct GMP audits of drug product and/or medical device manufacturers, as well as manufacturers of chemical raw materials and packaging components.
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Strong experience with GMP, GLP, GxP, and other relevant regulatory standards. Expertise in cell therapy manufacturing, cloud-based data management systems, and medical device remediation. Proven ability to act as a mediator and communicator between technical teams and regulatory bodies.
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Perform inspection and release of incoming GMP raw materials according to appropriate material specifications and standard operating procedures. Write and review investigations and product complaints to determine root cause and identify/implement related CAPA.
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ASQ Quality Engineer Certification (CQE)Six Sigma CertificationQuality by DesignApplied/industrial statistics experienceDetailed Knowledge of GMP, ISO and FDA design and development quality requirementsKnowledge of aseptic processing.
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Quality Assurance experience & knowledge of GMP required. Knowledge of Lean, Kaizen, and Continuous Improvement initiatives. Abiomed, part of Johnson & Johnson MedTech is recruiting for a Production Supervisor, 2 nd shift located in Danvers, MA.
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Genoskin is a Franco-American biotech company with research facilities in Toulouse, France, and Salem, MA. The company creates, develops and specializes in first-in-human data generation for drug & vaccine developers as well as cosmetic companies and academic institutions.
$65,000 a yearFull-timeExpandApply NowActive JobUpdated 6+ months ago
gmp job Company: Genoskin in Peabody, MA
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