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Training in a GCLP/GLP/GMP environment and other international regulatory guidelinesNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS This position may require occasional weekend and evening work to meet critical business timelines.
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Knowledge of the regulatory (cGMP, GLP, CBER, etc) and technical (production and testing methodologies of cell-based products. Experience with CAR T manufacturing and testing procedures.
$76,440 - $114,649.6 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Experience working in a regulated environment (GLP or GMP) Element Materials Technology Boston - Acton, Inc. is looking for a full-time Laboratory Support Technician to support our microbiology testing laboratory.
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2+ years’ experience in pharmaceutical industry with microbiological testing such as sterility/bioburden, new product validation, LAL testing and validation, microbial identification, gram staining, purified water testing as per USP, bacteriostasis and growth promotion assay.
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Additional participation and support of method transfer and validation of next-generation analytical procedures for the testing of viral vectors, cell banks, and gene therapy products to support uniQure's clinical pipeline and commercial products in compliance with company policies, procedures, and regulatory guidelines.
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Review early-stage analytical testing in support of GLP and GMP clinical protocols and production activities. QA Issuance, Review and Approval of manufacturing production batch records in support of 300 BMK manufacturing operations Perform walkthroughs and other support activities of Analytical Science and Process Development to ensure compliance with applicable GMPs/GLPs. Review of GMP/GLP documentation from manufacturing and/or Analytical Operations, which can include logbooks, and test records.
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Demonstrated knowledge of scientific applications, GLP regulations, experimental design, data evaluation, metric system, medical device testing, and technical writing. Supports lab with routine testing as well as evaluation testing for new or updated procedures.
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Under the guidance of the Quality supervisor, facilitate & assist in unique audit requests & testing when required. Adhere to basic principles of GLP & expand these practices department wide.
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It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations.
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The Quality Control (QC) Specialist II will be responsible for quality testing of fluorescently labeled bioconjugates and purified antibodies by way of flow cytometry. Experience working in a regulated environment such as GLP/GMP environment is a plus.
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Strong knowledge/proficiency required with lab techniques/instruments: microbiological testing, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, HPLC or GC and analytical balance, etc.
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Serve as the QC Subject Matter Expert (SME) for compendial requirements, raw materials testing, analytical methods, sampling, stability, and investigations to support Sana's cell therapy programs.
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Working knowledge of GMP, Food Safety, HACCP, GLP, GDP, EMP, and Quality Assurance programs. A Quality Assurance Supervisor works with the Quality Assurance Manager and supporting kitchen personnel in the recognition, prevention, and alleviation of food safety hazards; effectiveness of the sanitation program; and ensures the flow and testing of raw materials and finished goods is completed in a timely manner.
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Requires a minimum of eight (8) years progressively responsible experience in GLP lab work, performing varied testing and troubleshooting activities in high volume environment. Ensures timeliness and efficiency of product and material testing to meet production demands and promotes continuous improvement of departmental performance.
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Experience working in a regulated GMP/GLP environment Experience working with the Watson LIMS system is a plus Working knowledge in the use of ligand binding methods (ELISA, MSD, Gyros) Familiar with PK, ADA, and Biomarker data generated via ligand binding assays Frontage Laboratories Inc. is an equal opportunity employer.
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