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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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The Manager, Quality Control - Microbiology will lead and develop the Quality Control microbiological team while providing testing function oversight in support of environmental monitoring/utilities, raw materials, and in-process and finished products for ADMA Biologics production at the Boca Raton site.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Knowledge of the regulatory (cGMP, GLP, CBER, etc) and technical (production and testing methodologies of cell-based products. Perform internal audits, assist with manufacturing and QC site audits, provide document control functions, conduct failure investigations, assist with CAPAs, and coordinate the development and review of Standard Operating Procedures and Production Batch Records.
$76,440 - $114,649.6 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Experience in the manufacture of drug substance and/or drug product or quality control laboratories is desired. + Experience in a Quality Assurance, Quality Control or equivalent function is required.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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This role will be focused on supporting environmental monitoring and quality data review, with the opportunity to be involved in other aspects of quality control work. Participate within the Quality Control (QC) team to meet group and company goals.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Ensures Investigation/CAPA Quality System compliance as established in 21 Code of Federal Regulations (CFR) 210 and 211 Current Good Manufacturing Practices (CGMP) regarding quality methods and manufacturing and packaging processes and procedures.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Training or experience in environmental monitoring, microbiology, quality control, validation, technology transfer, change control. Accountable for the completion of Monthly and annual trending, EMPQs and related document updates, deviations and investigations related to environmental monitoring process, and the review and approval of completed production and laboratory documentation (for example: log books) for quality, completeness, and cGMP (Good Manufacturing Practices) compliance.
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Bachelor's degreeMinimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment. On-Board Scientific is hiring a Quality - QA Associate Specialist of Summit, NJ.
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Minimum of 8 years’ experience (or 6 years with advanced degree) in validation, biological quality assurance and/or quality control in an FDregulated biotechnology or pharmaceutical company with progressive levels of responsibility.
$134,400 - $184,400 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Champion the EHS, Lean and Quality strategy for the plant, demonstrating a strong and visible commitment to Company objectives; Ensure compliance with Company standards for cost control, waste reduction, improved efficiencies, quality, OSHA, safety and on-time delivery at the lowest possible cost.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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The Manager, Quality Control Lab is responsible for overseeing day-to-day operations of the QC Lab group. Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.
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The Contractor Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with client policies, standards, procedures, and Global cGMP. Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
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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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Knowledge of quality management systems (QMS), statistical process control (SPC), and quality assurance principles. Ensure compliance with relevant quality standards, regulations, and safety protocols, including ISO, FDA, OSHA, and cGMP requirements.
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Relevant experience in good laboratory/manufacturing practices (GLP/cGMP), laboratory quality control or stability, and interaction with quality assurance is required. Must be able to communicate effectively with manufacturing and quality.
ExpandApply NowActive JobUpdated 8 days ago
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