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The Quality Manager leads the continuous development, deployment, and improvement of the site Quality Management System (QMS) in Newburyport, MA which ensures a high state of cGMP compliance and supports the effective execution of UFPT objectives.
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In addition, our team also works on projects with clients to manage these Quality business processes for supply chain, manufacturing, commercial operations and R&D. This includes analyzing various cGMP and 21 CFR Part 11 regulations in the Regulatory Compliance area to determine impact on risk exposure.
$82,800 - $136,600 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Knowledge of cGMP requirements for life sciences projects. Strong understanding and knowledge of life sciences markets and processes (fermentation, cell / gene therapy, API, blood products, purification, fill / finish, medical devices, etc.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Creates proper laboratory records in accordance to cGMP and company Standard Opearating Procedures and Policies. Experience in regulated/cGMP environment is preferred. Perform all other tasks that will be oriented by the QC Supervisor, QC Manager or the QC Director.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Additionally, Microbiologist I, will be trained to perform Environmental Monitoring (EM) and Purified Water (PW) sampling in support of cGMP manufacturing activities associated with transdermal manufacturing.
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An operator will operate machines and handle components using prescribed standard operating procedures and cGMP guidelines to manufacture and ensure the product meets the quality requirements. Assure work center operates safely to produce products within established quality standards within the cGMP and SOP guidelines.
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Follow Prime Enterprises, Inc. SOPs, STPs and cGMP. - Keeps records updated, distributed, and filed. Education: Minimum of a BS in Chemistry, Chemical Engineering or Biochemistry. Candidate should have a solid working knowledge of laboratory instrumentation such as FTIR, HPLC.
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Adhering to cGMP standards and FDA guidlines. Our client, a reputable medical device company based in the city of Miami, Florida is seeking an experienced and autonomous Senior Quality Engineer to join their team.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines. Team lead/Supervisor experience. Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines.
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Review & Approve - cGMP SOPs, master and executed batch records, validation protocols, reports,specifications, and other related documents. Oversee equipment use and service agreements,maintenance, and calibration, manage stability program; Manage analytical software administration in compliance with 21 CFR parts 210 and 211; Serve as an SME for Analytical projects - method development, method validation, verification, and method transfer; Support quarterly and annual reports for products as applicable;Mentor and train Quality staff.
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The incumbent will be responsible processing human birth tissue in an FDA regulated environment and following all cGMP requirements. Record data following cGMP requirements. Perform general office duties such as: filing, typing, labeling, copying and shredding confidential documents.
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Understanding/Knowledge of global security frameworks and standards like CGMP, HIPAA, CIS, NIST, FIPS. 3 years of Network Systems Engineering work experience with extensive knowledge and familiarity with Aruba Switches, Access Points and Palo Alto Prisma SD-WAN.
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Develop and implement strategic plans to ensure compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., cGMP) for pharmaceutical manufacturing. Collaborate with cross-functional teams, including R&D, regulatory affairs, and supply chain, to support product development, technology transfer, and commercialization activities.
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Responsible for handling Biohazard waste and following all safety guidelines. Responsible for aseptic processing of birth tissue in a cleanroom environment, including processing area set up and change over as needed.
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Experience with aseptic processing, sterile manufacturing, and/or biologics manufacturing is highly desirable. This critical role requires a strategic leader with a deep understanding of pharmaceutical manufacturing processes, regulatory requirements, and quality management systems.
ExpandApply NowActive JobUpdated 8 days ago
cgmp job in Miami, FL
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