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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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Nine (9) years' experience in a Biotech/Pharma cGMP Manufacturing / Quality Operations environment required. Experience utilizing QMS software such as Trackwise, Master control, Vevva, EtQ Reliance, etc.
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Review/Approve Facilities, Utilities, Automation, Warehouse records to ensure compliance with approved directives/specification, site procedures and cGMP expectations Review/Approve quality system documents such as SOPs, Work Orders, others as needed Provide Quality oversight of facility related programs including calibration and maintenance, facility/utility monitoring, pest control.
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What makes you successful: Provide general oversite to team to ensure that all warehousing activities including but not limited to receiving, shipping, manufacturing support, and inventory control in compliance with Safety, cGMP, and Quality Standard Operating Procedures.
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Conversant with GLP/GCP/cGMP and global Drug and Device Development Processes. Responsible for Chemistry and Life-sciences related disciplines performing basic and applied research to provide innovative solutions for reducing hospital acquired infections and improving the quality of health care.
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No Shore Options Available for this Position Onshore Only Attachment: JOB DESCRIPTION JOB TITLE: QC Analyst I Microbiology JOBCODE: OS FLSA: Non-Exempt DIVISION/SITE: Memphiscog DEPARTMENT: QC Micro REPORTS TO: Supervisor QC Microbiology ORIGINAL DATE: -Jan- LAST REVISED: -MAR- BASIC SUMMARY: The Quality Control Analyst I for the QC Microbiology Department will be responsible for performing processing of routine environmental monitoring samples, product-release testing, and raw material testing.
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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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This individual will join the Quality Control leadership team supporting the GMP manufacturing facilities in Redmond, WA and Seattle, WA. As the QC Stability and Sample Management Manager, you will be responsible for the daily oversight for the QC stability and sample management operations in support of routine GMP operations at Just-Evotec.
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Audits the fresh DF in accordance with FDA cGMP guidelines, the DF Food Safety Plan as it pertains to the Preventive Control Rule, and the DF Seafood HACCP plan, with oversight of the QA Supervisor.
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8+ years’ experience in managing quality control, quality assurance, and food safety in a food processing environment. Lead a team to maintain Quality and Food Safety Management System requirements throughout the manufacturing and supply chain process to ensure execution and compliance with company policies / processes, regulatory requirements, cGMP, ISO, and other Industry standards.
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Experience: Minimum of 2-4 yrs working experience in a cGMP Quality Control, analytical development, analytical transfer or validation department in a FDregulated industry. 12 monthsLocation: Exton, PAAs a Quality Analyst, your responsibilities:Description: The QC Analyst 2 will contribute to the success of the operation by providing accurate, GxP-compliant analyses of clinical biopharmaceutical products and by participating in assay qualification and validation studies.
$29 - $30 an hourExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Experience working within a rigorous, quality control environment such as FDA cGMP/QSR or ISO preferred. Recording of lot control, inspection results, test results, yield information and other data as required onto Solta traveler documents of other data collection devices.
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SPL has an exciting opportunity to join the team as a Supervisor, Quality Control. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs.
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Performs analytical testing in the Microbiology Quality Control laboratory. Keywords: Microbiology, Microbiologist, QC, Endotoxin, Environmental Monitoring, cGMP, EM. 1+ years of experience working in a cGMP microbiology laboratory.
$60,000 - $80,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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2+ years of document control and reporting experience in cGMP/FDA regulated setting. Proficient in technical writing, MS Office, Document Management Systems, and Quality Management Systems; experience with Veeva Vault is preferred.
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