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Partners with relevant functions to ensure GMP, GLP and GCP compliance for all clinical development programs by providing guidance and serving as an expert in the interpretation of regulatory requirements and expectations.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Medical device 510K, Predicate rules, ECTD,21 CFR Part 11, 210, 211, 312, 314, 820 GXP, GMP, GDP, GLP, CAPA. HL7, HIPPA, SOP, SQL, HTML, XML, EDI, Silk, Client Quality Center, Jira Confluence, Microsoft TFSLIMS.
ExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Build and lead the Global Quality Assurance, Clinical Development and Operations function, while maturing and maintaining Quality oversight of GCP/GVP/GLP activities from pre-clinical through commercialization; ensuring all aspects are inspection ready and compliant with applicable regulatory requirements.
$240,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Assists in the development of internal and external GLP/GCP/GVP annual audit plan for sites and vendors and update the audit plan as needed based on identified risks and trial priorities. 5+ years experience in a Quality Assurance role, GLP/GCP/GVP, including both external and internal audits.
$165,000 a yearFull-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Design and execute synthetic processes to produce drug substance for GLP tox and clinical supplies. Proven track record in developing and scaling up chemical processes from laboratory scale to kilolab, pilot plant, and commercial plant.
Full-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Lead identification of assay requirements, lab selection, and contract development to ensure regulatory compliance according to GLP, GCP, and applicable global regulatory requirements such as CLIA and EU IVDR, and execution feasibility.
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We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.
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Work with the BST network of specialty labs to support delivery of high quality bioanalytical and biomarker data to clinical programs, ensuring adherence to the requirements of quality, and ethical and regulatory standards, including ICH/GDPR/GCP/IVDR/GLP.
$209,000 a yearFull-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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Working knowledge of Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP) and other regulatory/procedural requirements at all times. Setup and operate all equipment including Brush washer, Centrifuge, Urschel Mill, Rotary Vacuum Dryer, Fitz mill, and Rando Webber.
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Experience with GMP, GLP, GxP, Lean, Agile Software Development Lifecycle Procedure. Expertise in cell therapy manufacturing, cloud-based data management systems, and medical device remediation.
ExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Familiarity with GLP (good lab practices) and food safety certification - HACCP is a plus. The Lab Manager - R&D will report to the Associate Director of Innovation, with day-to-day responsibilities that include managing a robust product development pipeline that includes rapid concept development, existing formula optimization, and validation of new ingredients and suppliers.
$140,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Serve as the subject matter expert on cross-functional teams to lead projects, direct GLP bioanalytical validations and sample analysis across all nonclinical, DMPK and clinical pharmacology development.
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Combining of FIM programs with other medical treatment paradigms, such as GLP-1 agonist therapy for weight loss; The Food is Medicine Institute, Tufts University School of Medicine, Friedman School of Nutrition Science & Policy, and jointly seek to hire a faculty member with a strong track record or promise to advance original research and impact in the area of Food is Medicine (FIM.
Full-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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Provide quality oversight of internal and external clinical functions, ensuring that operations in the clinical functional areas are compliant with GCP, GLP, relevant Regulatory (FDA, etc.) Experience in training staff on GCP and GLP principles, processes and procedures.
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In-depth knowledge of GxP guidelines (GMP, GLP, GCP, GDP, GVP) and regulatory requirements (21 CFR Part 11, EU Annex 11). In-depth knowledge of GxP guidelines (GMP, GLP, GCP, GDP, GVP) and regulatory requirements (21 CFR Part 11, EU Annex 11.
$60 an hourExpandApply NowActive JobUpdated 12 days ago
glp job in Woburn, MA
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