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The Sr Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as varied vendors supporting Clinical Studies.
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Lead and manage commercial QA oversight program including manufacturing, packaging and labeling, serialization, direct to practitioner sample program, third party logistics activities, to ensure compliance with DCSCA and associated regulatory requirements.
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Reporting to the COO, The Vice President, GxP Quality Assurance is responsible for establishing and leading Aveo's Quality Management System (QMS) operations and ensuring compliance with Local, State, Federal, and International regulations and standards associated with GXPs and Quality Systems in a fast-paced, primarily virtual development environment.
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Innovate and optimize in the fields of microfluidics, heat transfer, optics, and sample preparation. Expertise in advanced interdisciplinary systems such as optics, fluidics, and thermal management of biological samples.
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Work/Life and Wellness: Child and elder/adult care resources including on campus childcare centers, Employee Assistance Program, and wellness programs related to stress management, nutrition, meditation, and more.
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Go sailing or whale-watching, take a ferry to Martha’s Vineyard, sample just-caught lobster or simply unwind on a wide open stretch of beach on this beautiful peninsula. Travel nurses may find themselves in challenging situations that require effective crisis management.
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B.A, B.S. in Biotechnology, Biology or Management, or related degree with 1+ years of sample management and/or sample logistics experience in a pharmaceutical, diagnostics or related research setting.
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Reviews study sample metadata to confirm consistency between the tube labels, study paperwork and electronic sample management systems (eSMS) The Sample Management Technician is responsible for GxP-compliant processing of incoming samples and reference materials.
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Responsible for efficient management of agreement deliverables, sample/tissue custody and record keeping, aiding in the development of critical workflows and procedure as they relate to various grants and contracts, and improving/streamlining current workflows and systems within the Ghobrial Lab.
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Ability to operate PCR apparatus, including managing sampling schedule, sample preparation, managing consumables inventory, data management and results interpretation. Ability to perform all microbiological testing operations on wort & beer, including yeast cell counting, pitch rate determination, microbiological media preparation, sample collection using aseptic technique, microbiological screening of yeast, wort & beer samples, sterile filtration of beer samples, assistance with barrel sampling projects and yeast propagation as needed.
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Minimum 15-20 years of experience in biotech/pharmaceutical industry; Minimum 10 years at a senior management level. Oversee the inspection readiness, risk management, and metrics & reporting programs.
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In this role you will assist with QC data trending projects, sample/reagent inventory management, and LIMS master data. Reporting to the Manager of QC Logistics, he/she assists in developing tools to improve management of sample and/or reagent inventory.
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Assist in QC sample management for internal and external testing samples. Capable of completing assigned responsibilities under minimal supervision and keeping management informed of work status.
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Utilize the Laboratory Information Management System (LIMS) to track and execute sample processing. The Molecular Technologist I performs procedures in a complex patient sample testing process with limited supervision.
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Manage operational aspects of the QC laboratory including scheduling of GMP testing, stability studies and logistics, sample management and the critical reagent program. Experience in supporting or leading laboratory operations such as logistics for GMP manufacturing, logistics for stability testing, management of sample inventory and/or management of critical reagent program.
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sample management jobs in Boston, MA
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