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In the absence of the Quality Assurance Technician, the QA Manager or designate will assume the job duties. Must follow GMP Policy - wear company issued shirt, hat, safety glasses, earplugs and hairnet in production areas.
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Interact with global and cross-functional members from systems engineering, process engineering, device development, packaging, primary containers, device quality, and other groups. Test activities will include Engineering, characterization and GMP verification testing and will require a strong proficiency in developing test protocols, statistical analysis, executing hands on testing, and reporting of results to senior leadership.
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Minimum of 10 years’ experience in GMP QC/QA/Quality Systems, Microbiology or Analytical Development in biopharma/pharmaceutical industry. Provide guidance, advice, and support for GMP quality and compliance matters related to analytical testing and other related activities.
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Innova Solutions is immediately hiring for a Quality Assurance Specialist - 3r d Shift. Perform QA in-process inspections for each department/line once per shift by checking the following: production paperwork, retain sample, code date/lot number/best by date, weight check documentation, metal detection documentation, label, color code, department cleanliness employee GMP practice and checking for any potential allergen cross-contamination.
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Interface effectively with all Management, Quality, Support and Research staff, Technology, Facilities Maintenance, Supply Chain, Customers, Contractors and Visitors, and Auditors. GMP DECISION-MAKING AUTHORITYReview and approve documents as required, i.e., deviation reports, purchase requisitions, new and revised batch record formulations, etc.
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Implement and maintain Electronic Records Program (ERP), Quality Management System (QMS), and applicable Quality Standard Operating Procedures (QSOPs) as directed by Head of QA/QC. Coordinate and lead annual GMP and Food Defense reviews and exercises and oversee the completion of any follow-up/action items with oversight from Head of QA/QC.
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We are currently seeking an industry leader for a Director, Quality Assurance role, who will report to Executive Director, Supplier Quality Management and Audits, within the Global Quality Systems & Compliance department.
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Completes shift reports for production numbers, downtime, attendance, overtime and quality checks for submission to the Production Manager. Verifies discrete jobs are correct in Oracle (including quality and bill of material list), Warehouse Management System, and/or Line Management System.
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In collaboration with the relevant team members, you will be responsible for identifying, selecting, negotiating agreements with, and managing various CMC vendors including, but not limited to, those providing raw materials (APIs, excipients, packaging), packaging, labeling, shipment services, GMP storage of API, Drug Product, and final finished goods.
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Facilitate GMP product readiness and launch activities, including stability strategy, technology transfer and validation. The Senior Quality Assurance Specialist provides Quality support for Petaluma site and ensures adherence to cGMP compliance in a regulated environment.
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Attend required training, including but not limited to, Safety, GMP, Hazard Analysis and Critical Control Point (HACCP), Preventive Controls Qualified Individual (PCQI), and Safe Quality Foods (SQF.
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High level experience of in food safety and quality regulations and standards (GMP, GFSI [SQF, BRC, other benchmarked scheme], HACCP, SSOP), government regulatory requirements, food safety, food manufacturing processes, technologies or other relevant area of responsibility.
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The QA Specialist is responsible for monitoring products and employee practices on the manufacturing floor to insure the safety and quality of products manufactured by Georgia Nut Company. Monitor GMP on the floor and send out daily report of issues noted.
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This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.
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Recognizes environmental, safety, and GMP hazards and identifies, discusses, and contains them to keep from affecting employee safety, product quality, and environmental purity. Makes recommendations for improvements to company safety and environmental programs, quality and good manufacturing practices and production and material handling procedures.
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