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We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.
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Knowledge of GLP/GCLP and GCP global regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS). Extensive experience managing deviations, RCA and CAPAs in a GLP/GCP environment.
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Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy (deep experience with GLP or GCP preferred.
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About Research Models & ServicesFundamental to basic research and discovery is the use of in vivo models to help identify disease targets and determine potential biological pathways that regulate the condition.
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Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture. The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.
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In-depth working knowledge of the applicable cGMP/GCP/GLP/GVP regulations and guidelines in a pharmaceutical environment. This role will develop strong relationships, collaborate, and interact with various departments (i.e., Quality Operations, Quality Systems, Chemistry Manufacturing, and Controls (CMC), Analytical, Regulatory Affairs, Pharmacovigilance, Procurement), and all levels of management at Akebia to accomplish company objectives.
$189,501 a yearFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Strong background in GLP and cGMP standards, with hands-on experience in assay development and validation. Strong background in GLP and cGMP standards, with hands-on experience in assay development and validation.
$32 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Lead investigations into significant quality issues, scientific misconduct and suspected serious breach of GCP or GLP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate.
$200,000 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Partners with all line functions to ensure GMP, GLP and GCP compliance for all clinical development programs by providing guidance and serving as an expert in the interpretation regulatory requirements and expectations.
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Working knowledge of cGMPs, GLPs Strong knowledge of Trackwise to handle electronic Quality Manage System (eQMS) data Strong familiarity with regulatory/compliance environment (cGMP, GLP) associated with parenteral drug manufacture.
$118,000 a yearExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Strong knowledge of engineering standards and all applicable regulatory requirements including: Building Codes, Factory Mutual, Environmental, GMP/GLP, OSHA and ADA. Minimum of 10 years demonstrated Project Engineering & Management experience leading cross-functional project teams for design, construction, commissioning & qualification, and start-up with a proven track record of on-time & on-budget performance for complex projects related to Pharmaceutical Manufacturing Facilities.
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Successful candidates will be responsible for contributing to Fractyl’s lead and pipeline programs with a primary focus on design, management, execution, analysis, and data reporting of non-GLP and GLP in vivo studies to evaluate delivery, efficacy, safety, and pharmacology of AAV-gene therapy candidates in various animal models.
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Certification in pharmacovigilance (e.g., RQAP-GLP, PVQA) or quality management (e.g., ASQ Certified Quality Auditor) is a plus. Minimum of 6 years of experience in drug safety/pharmacovigilance quality assurance or compliance within the pharmaceutical or biotech industry.
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Located in the suburbs of Boston & Cambridge, they are seeking an experienced Process Chemistry leader to design, execute, and lead chemical process development and manufacturing strategy to produce drug substances for GLP toxicology, clinical supplies and potential commercialization.
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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.
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glp job in Burlington, MA
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