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Hplc, sap, Karl Fisher, FRIT, uplc, GC, gas chromatography, raw material, Chemistry, Quality control, Analytical chemistry, Gmp. Ensure compliance to all data integrity and cGMP practices, and procedures, and expect.
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Reports to Quality Control Manager. Proficient in SOP, Protocol, Report authoring, Method validation execution using cGMP/GLP. Authority to place product on hold for quality deficiencies.
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This role is responsible for overseeing routine virus and mycoplasma testing (cell-based and molecular biology assays) of manufactured commercial and clinical products according to cGMP, ICH guidelines, and associated standard operating procedures.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Review Quality Control documentation to ensure compliance with company procedures and cGMP and support issuance of CoAs and stability studies. This position will report to our Quality Assurance Manager and focus heavily on reviewing documentation such as batch records, internal audits, and ensuring cGMP compliance.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Jump site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and retention of GMP records.
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Completing work orders, logs and forms following cGMP documentation practices and Quality Standards in a Pharmaceutical Manufacturing facility is mandatory. This entry-level position performs daily checks and maintenance on facility equipment and systems while adhering to cGMP standards and corporate safety policies.
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Review records related to the general operation and upkeep of a GMP Quality Control laboratory, including but not limited to, QC test data, Quality Event (QE) documents, qualification documents, and validations.
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2-4 years professional experience in food, dietary supplements quality assurance, quality control, or related field. You will follow our internal quality management system, as well as cGMP and GLP standards.
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GMP, Contract Manufacturing, inspection, quality assurance, Aseptic Technician, Aseptic, Sterile, Sterile Injectables, Injectables, Document control, Compliance, Quality control, Filling, Aseptic technique, kitting.
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Artiva Biotherapeutics is seeking a skilled and motived Quality Control Associate for Environmental Monitoring (EM) who will be reporting to the Supervisor of Quality Control.
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Requirements: Associate degree in a Life Sciences discipline 2 years of relevant experience working in cGMP cleanrooms Experience working in cGMP Quality Control Able to work off hours or weekends as needed LIMS or MODA experience a plus Experience conducting bioburden and membrane filtration testing a + Powered by JazzHR.
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The Quality Assurance Specialist (eQMS and Document Management) is responsible for serving as one of the administrators of Knippers electronic quality management software (e-QMS) system and back-up to the supervising CAPA Manager; independently supporting investigations, CAPA implementation and Effectiveness Check plans as well as Change Control.
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The Analyst II, Quality Control, will be responsible for method development, transfer qualification, validation and performing various in vitro assays to support drugs and clinical product development.
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Ideal candidates should have 2+ years of Document Control and report experience with at least 1 year being in cGMP/FDA regulated environment. Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.
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Minimum of 10-15 years' experience in validation (with degree 10+: without 15+), biological quality assurance and/or quality control in an FDregulated biotechnology or pharmaceutical company with progressive levels of responsibility.
ExpandApply NowActive JobUpdated 4 days ago
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