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Food Safety, Food Security, Allergen, FSMA, RSPO, GMP training for plant; complete GMP/Quality tool box meetings with all employees. Manufacturing facilities are located in Dallas and Houston, TX; Decatur and Quincy,IL; Englewood, NJ; Fresno, CA; Nashville, TN; and Valdosta, GA. Corporate offices are located in Memphis, TN.We arecommitted to maintaining a progressive workplace by utilizing the ideas, skills and talents of all of our employees.
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Support and track deviations, investigations, and CAPA plans for the GMP Facilities Department Role will include conducting detailed investigations to determine root cause and necessary CAPAs by working cross-functionally with Facility Management, QA, Validation, and Business Area Management.
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POSITION REQUIREMENTS: " Bachelor's degree in a Scientific, Engineering or Biotech field with 4 years' experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance.
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The Quality Manager supports the Sugar Cone and Cake Cone production facilities at the Hermitage, PA location to facilitate and maintain the food safety and quality programs in coordination with Production, Warehouse, Maintenance, Procurement, and Sanitation departments.
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As a member of UDC’s Chemical Business, this position will work closely with UDC’s HQ team, UDC’s contract manufacturing partner (PPG), and other UDC subsidiaries in the development and manufacture of UDC’s OLED materials in a fast-paced, non-GMP environment.
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Summary: We look forward to welcoming a Bioprocess Engineer with a solid understanding of bio-chemical engineering fundamentals and modeling expertise to support our laboratory, pilot and clinical scale process development, technology transfer to internal and external GMP production facilities for our novel cell free expression-based therapies.
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The incumbent will provide Automation support to the daily operations, continuous improvement, and projects for the Pilot Plant, Bulk Manufacturing, Filling, Assembly, Packaging, Utilities, Facilities, and other DCS and PLC Automated Equipment and Control Systems on a GMP regulated environment.
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As a scientist in the Purification Development group, you will identify and develop new purification technologies, work to design optimized downstream drug substance processes for new biologic candidates, employ strategic thinking to overcome technical hurdles and oversee process technical transfer to GMP manufacturing facilities, as they make their way from discovery to the clinic and eventually commercialization.
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Complies with Safety, PSM, environmental, SQF, GMP policies, procedures and regulations. Supports weekly work order schedules as arranged by Facilities Maintenance Planner. Supports Break-Down-Analysis (BDA) and 5S for assigned Facilities areas and supports and actively participates in continuous improvement activities through the company performance system.
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This individual will join the Quality Control Bioassay team supporting the GMP manufacturing facilities in Redmond, WA and Seattle, WA. The role is responsible for conducting routine/non-routine testing and analysis of GMP product using methods such as ELISAs, qPCR, and cell-based assays at both Washington state facilities.
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SQF, ISO, GMP, ASQ, HACCP or similar certification experience preferred. The Quality Assurance Manager is responsible for managing and enforcing all quality assurance and (QA) operations at GTI's production facilities.
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Summary: The purpose of this position is to routinely monitor the operation and efficiency of two Pharmaceutical Clean Room facilities and a GMP Warehouse, making adjustments and corrections to maximize uptime and energy efficiency.
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Hands-on experience with ISO clean rooms and a strong grasp of General GMP knowledge in pharmaceutical manufacturing facilities. 10+ years of relevant experience in facilities management, preferably in pharmaceutical manufacturing.
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Must be knowledgeable of FACT, FDA (GMP/GTP regulations, etc), AABB, JC, CLIA, OSHA and Massachusetts DPH regulations. Performs GAP analysis to ensure the department is compliance with all newly introduced requirements of regulatory and accreditation agencies to include: FACT, FDA, JC, AABB, CLIA, DPH and OSHA. Performs external audits for services that CMCF contracts out to other facilities Performs other duties as assigned.
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The Facilities Maintenance Technician will follow all appropriate factory GMP, food safety, safety and quality policies, and will perform miscellaneous duties assigned by Sr. Maintenance Technician, Maintenance Leader, Value Stream Manager and Technical Manager.
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