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The scope of this role includes ensuring Good Manufacturing Processes (GMP) and Good Laboratory Practices (GLP) compliance and quality systems at Pliant and its vendors. The ideal candidate will have extensive experience leading GMP/GLP Quality Assurance activities and deep understanding and demonstrated working knowledge of Code of Federal Regulations (CFRs), ICH guidance documents, and other regulations that govern GMP/GLP compliance during clinical development and commercialization of drug candidates.
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Expertise in Quality Systems and cGMP standards applicable to method validation for clinical and commercial products and AO/QC laboratory operations. Experience in a Pharma / Biotech GMP environment and a Bachelor's degree in chemistry, biology, or related scientific field.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Possesses experience/knowledge in laboratory controls, method validation and method transfer guidelines per FDA/EU/ICH/USP/JP guidelines. Strong background in laboratory investigations (OOS, OOT, Atypical), deviations and associated CAPAs.
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Tech transfer to CMO and scale-up of chemistry, including supporting GMP manufacture. We are seeking a highly motivated process research and development chemist with a proven record of sustained laboratory achievement and innovation to join our growing CMC group at ORIC Pharmaceuticals.
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Gain knowledge of GMP laboratory processes and electronic systems widely used in Pharmaceutical Industry. Apply analytical chemistry knowledge and learn analytical laboratory skills in Pharmaceutical Industry.
InternExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Adhere to FDA Good Practices (GMP, GTP, GLP, GDP), International Organization of Standards (ISO), College of American Pathologists (CAP) standards and other regulatory requirements as outlined in SOPs.
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Qualification of various Analytical Laboratory Instruments and Software including HPLCs, UPLCs, GCs, Ovens, Karl Fischers, FTIRs∯*∯ Validating LabX, Empower and Agilent OpenLab software with a focus on data integrity.
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Working knowledge of GxP regulations Strong technical knowledge of GMP and/or GCP regulations and eQMS systems; experience with ArenaPLM administration strongly preferred. Associate or Bachelors degree in related technical field or equivalent practical experience (3+ years working experience with Associates, 1+ year with Bachelors) 4+ years of work experience, preferably in a regulated industry, e.g., medical device, pharmaceutical under good clinical, laboratory, manufacturing, and distribution practice (GxP) environments.
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Responsible for supporting and maintaining the GMP clinical/commercial manufacturing and facility process equipment, Pilot Plant and QC laboratory equipment. The GMP Lead Maintenance Technician: A motivated self-starter with prominent levels of initiative.
$31 - $42 an hourFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Work closely with Quality Control (QC) and Analytical Development and Operations (ADO) personnel to determine laboratory needs and user requirements. Collaborate with validation team members during qualification activities for GMP systems.
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This individual will work with project teams consisting of cross-functional team members from metrology, validation, quality control, analytical, quality assurance, and facilities operations to ensure efficient completion of these laboratory-based projects.
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For Benchling, regulated labs encompass labs working under both Good Laboratory Practices (GLP), for example bioanalytical labs, and Good Manufacturing Practices (GMP), for example quality control labs.
$219,980 - $297,620 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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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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Facilitate the demonstration of new laboratory systems as needed. Manage laboratory operations projects: including the installation of new analytical instruments and equipment, new software, relocations, and process improvements.
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Apply analytical chemistry knowledge and learn analytical laboratory skills in Pharmaceutical/Biotech Industry in a GMP QC environment. Follow written procedures to conduct GMP analysis using various analytical techniques such as appearance, pH measurement, solution preparations, Fourier transform infrared (FTIR), water content by Karl Fischer, UV-Vis spectrophotometry, dissolution, etc.
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gmp laboratory jobs in South San Francisco, CA
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