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Additional duties as may be assigned from time to time Education & Qualifications 4 years of experience in the pharmaceutical/biotech industry Demonstrated aptitude or ability to learn to gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards.
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Ability to document experimental results to GLP/GMP standards. Ability to work in a Biosafety Level 2 lab. Ability to document experimental results to GLP/GMP standards. Must be able to wear personal protective equipment (gloves, face shields/safety glasses, latex, or nitrile gloves, etc.
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0 to 2 years GMP/GLP experience. The QC Analyst I is an entry-level, non-exempt position that reports to the QC Management Team. The QC Analyst I is responsible for performing quality control testing on various state-of-the-art diagnostic tests, components and standards for the food and beverage industries.
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The Compliance team will be primarily responsible for closure of any investigations and ensure compliance with GLP, GMP, and QMS standards. The Compliance team will be primarily responsible for closure of any investigations and ensure compliance with GLP, GMP, and QMS standards.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Ensure projects are carried out in compliance with regulatory requirements (GMP, ISO, MDD/MDR) & LeMaitre policy & procedure requirements. Ensure projects are carried out in compliance with regulatory requirements (GMP, ISO, MDD/MDR) & LeMaitre policy & procedure requirements.
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Applies advanced working knowledge and experience to independently improve maintenance techniques and operations in a highly regulated GMP environment under the guidance and direction of the Maintenance & Facilities Manager.
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Troubleshoot/ repair electro-mechanical machine failures by disassembly and inspection of components. The Manufacturing Maintenance & Repair Technician will perform preventive maintenance, diagnostics, and repairs to machines and equipment.
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Experience working in a SOX/GMP Validated environment a strong plus. SOX/GMP Validated environment: 3 years (Required) Ensure functional work activities are conducted in compliance with technology and GMP requirements, related policies and procedures, and corporate objectives.
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The Complaint and Training Coordinator plays an integral role in ensuring that the company is compliant with complaint handling documentation and reporting activities as well as training documentation activities relative to the company’s GMP system.
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Complete and maintain build paperwork in accordance with ISO and GMP Standards. Position : Production Operator II I. Complete and maintain build paperwork in accordance with ISO and GMP Standards.
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Receiving, aliquoting, distributing, handling and documentation of GMP samples in support of multi-product and multi-site testing laboratories. Knowledge of GMP concepts. We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.
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The micro-cleaner is a critical role in the company which ensures the proper cleaning of the cleanroom, controlled environment and GMP laboratory environments. Responsible for participating in continuous training: cGMP training, technical skills, safety, performance improvement.
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