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The QAU will support the comparable GMP production activities related to GLP toxicology lot production and technical transfer activities as it relates to clinical batch release testing conducted at GTP to support the clinical CMO. The QAU will also provide Quality Assurance support to the research-based portion of the GTP, in terms of SOP management, training, document management and archiving, and audit support.
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This individual will foster collaborations between ABS Operations, R&D, Manufacturing, and Akoya’s IVD Program Management Team to ensure the highest possible quality outcomes, while focusing on the implementation and daily maintenance of a Quality Management System (QMS) in a CLIA, GLP and GCP setting.
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He/she will lead a team who primarily perform GLP Test Item characterization, cGMP release and stability testing, and interfacing across the NCE project team and fulfill responsibilities of a GLP Principal Investigator.
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Certified Group includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, Labstat International Inc., Advanced Botanical Consulting & Testing (ABC Testing Inc.), Microconsult Inc., and Micro Quality Labs Inc. Certified Group provides laboratory testing and regulatory consulting services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, tobacco, nicotine, cannabis, hemp, and other industries.
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Familiarity with GLP, OSHA guidelines, FDA, BAM, APHA, ISO, and USP methods and procedures. Certified Group is a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services.
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The Laboratory Technician I performs cell culture and cell-biology based assays according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs.
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Conducts cell culture assays and lab procedures according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs. Under direct supervision, completes batch records and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Performs additional Research & Development activities as required.
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The ideal candidate should possess a strong background in chemistry, have a thorough understanding of cGMP, GLP, GDP guidelines, and be proficient in utilizing analytical instruments such as FTIR, HPLC, and ICP. Additionally, the Lab Chemist will collaborate closely with third-party laboratories, manage sample submissions, and generate Certificates of Analysis (COAs) to meet industry standards and regulations.
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Perform analytical and microbiological testing of food products, ingredients, and environmentals. Two or more years of experience in a commercial food-testing or analytical laboratory. Broad knowledge of concepts, practices, and procedures of a food testing laboratory.
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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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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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The Senior Bioanalysis Scientist I is responsible for assay development, validation, and sample testing to support non-clinical and clinical studies for a fast-growing Exelixis pipeline of novel biotherapeutics.
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Ensure that testing meets international and domestic biocompatibility test requirements according to ISO, FDA, EU MDR, GLP, Japan, and APAC countries. Experience in polymer chemistry and pre-clinical science/biocompatibility testing in medical devices also preferred.
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Report inventory and expendable supplies/materials needed for testing requirements. We are currently looking for a Pathogen Lab Analyst to join our growing team! Assist in quality duties to by taking incubator temperatures, inoculating control organisms, running media controls, etc.
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Senior QA Auditor is responsible for reporting any findings to the Study Director or Responsible Person and Testing Facility Management. The Senior QA Auditor is responsible for carrying out systematic and independent examination (i.e., audit) of multiple study related activities and documents, to determine whether the evaluated study related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), GLP (21 CFR Part 58 and Part 11) and the applicable regulatory requirements.
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