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Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Looking for one experienced Chemist and one Microbiologist to review and approve tests in LIMS and work on special projects.
$40 an hourFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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This person must comply with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Laboratory Safety and any regulatory requirements. Lief also houses a state-of-the-art, full-service Current Good Manufacturing Practice (cGMP) manufacturing facility, which offers custom solutions for a multitude of supplement categories.
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Support laboratory equipment qualification Support test method validation Support laboratory investigation and conduct nonconformance investigation Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
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Knowledge of cGMP manufacturing. Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework with 0-2 years experience. Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment, and CIP/SIP systems.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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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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Collaborates with internal functions and aligns goals and objectives for pre-clinical to commercial phase programs and products, ensuring cGMP, GCP, GVP and GLP compliance and realization of other value-added guidelines and best practices.
$315,000 - $320,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Knowledge of GLP, cGMP, and ICH guidelines; Compile and review all results from instruments and Watson-LIMS database for report writing; Discounts on local sports games, local fitness gyms and attractions Official Sponsor of FC Cincinnati.
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Certificates, Licenses, Registrations: Brewing science, cGMP, or Cicerone program certificates a plus. Experience in a professional laboratory, brewery or food/beverage manufacturing experience, with GMP/GLP a plus.
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Relevant experience in good laboratory/manufacturing practices (GLP/cGMP), laboratory quality control or stability, and interaction with quality assurance. Perform routine ICP-MS and ICP-OES analysis for trace metals in a GMP analytical laboratory.
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Strong knowledge of regulatory requirements and guidelines (e.g., cGMP, GLP, ICH) governing pharmaceutical manufacturing and testing. Overview : The QA/QC Analyst at AstraZeneca is likely responsible for ensuring the quality and compliance of products and processes within the company's pharmaceutical manufacturing or research facilities.
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The Associate Scientist - Microbiology performs and directs 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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At least 10+ years of experience pharmaceutical or biotechnology industry cGMP experience with 4+ years of relevant experience in GMP Quality Assurance. In-depth knowledge of ICH, FDA, and EU GMP and GLP regulations with all phases of drug development.
$100 - $130 an hourPart-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Familiarity with ICH guidelines and cGMP and GLP regulations. Adhere to all GMP/GLP requirements. Familiarity with thermoplastic polymers and polymer chemistry and injection molding.
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May serve as study director, principal investigator, or project leader for GLP and CGMP studies. Completes complex work for research and development, CGMP and GLP studies and documents and reports data in a timely manner according to regulatory guidelines.
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Knowledge of GLP, cGMP requirements and familiarity with USP/ICH guidelines is preferred but not required. Serve as mentor to Quality Laboratory Associate (QLA) I positions. Knowledge of Empower Chromatography Data System and LIMS is preferred but not required.
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