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Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles Position Reports to Jenna Walker – Associate Director, QA Training & Document Control Education: Bachelor’s degree or equivalent Key Requirements and Technology Experience: Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.
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Comply with SQF, Food Safety Plan (HACCP), and Food Quality Plan (FQP) standards; Responsible for ensuring compliance with FDA and cGMP standards for Quality Control, including continuous training; Responsible for ensuring Dietary Supplement’s Identity, Purity, Strength, and Quality.
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0-2 years of relevant experience within a cGMP Quality Control setting, preferably in the pharmaceutical or biotechnology industry. Experience in cGMP aseptic processing facility is a plus.
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This includes performing analytical methods, data review and trending, and implementation of GMP operational support systems ensuring a compliant Quality Control lab. The candidate will interface with multiple Quality Control functions in support of method qualification, transfer, and validation activities.
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Maintain and manage cGMP and general lab systems at defined levels of compliance. Familiarity with compliance requirements within cGMP, safety and regulatory environments. Together with our customers, we aim to improve the quality of life for patients around the world.
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Experience with cGMP documentation systems and with implementation of quality control systems. Performs microbiology department related raw material, in-process, and finished product testing according to USP methods and established procedures that follow cGMP guidelines and demonstrate outstanding aseptic techniques.
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Performs document control functions to ensure the integrity of all Stability and QC Laboratory records in accordance with cGMP requirements. Ensure the quality of products produced at Playtex Business Unit is consistent with EPC / Playtex Mfg. Inc. Quality standards.
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This position is responsible for performing inspections, batch record review, and quality system functions in accordance with cGMP and related company SOPs, state, federal and local laws as applicable.
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Key Duties and Responsibilities: Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into phase appropriate control strategies Leads and drives improvements to quality governance forums identifying risks and driving overall compliance and quality maturity Provides oversight, support, and drives continuous improvement to quality systems such as change control.
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Review and approve in-process quality control data, change controls, deviations, and test results for timely disposition of cell therapy products for human clinical use. Execute bio-analytical, cell-based, microbiological and/or molecular methods for product release in the Quality Control laboratory.
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Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (Agile, Trackwise, LIMS, Master Control, ERP, etc. This role is responsible for Quality Engineering support of a recently built enzyme manufacturing facility serving pharmaceutical customers.
$83,300 - $125,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Key responsibilities are performing GMP tasks associated with maintaining compliant Quality Control and Stability laboratories; providing sample management support for QC; and creating, reviewing and approving documentation.
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Follow all laboratory SOPs, including but not limited to laboratory safety, chemical handling and storage, gowning, equipment use, cGMP, GDP, data integrity, DEA requirements, etc. Identification and isolation of infectious disease-causing organisms which may be present including Bacteria, Yeast & Mold, and other pathogens.
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The Quality Control Analyst compiles data for documentation of test procedures that may include stability program testing and formulation studies, participates in the preparation of investigations, summaries and reports, and reviews data obtained for compliance to specifications and reports out-of-trend and/or out-of-specification results.
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The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting.
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