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The ideal candidate will have a deep understanding of food manufacturing processes and regulatory requirements, including SQF, HACCP, FDA, Quality, GMP, Batch Record Review, QMS, and Dairy.
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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.
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Thorough understanding and working experience in drug substance development and manufacturing with respect to quality by design, GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
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Thorough understanding and working experience of pharmaceutical drug products concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements. Pharmaceutical Development, late-phase drug development, CMC, small molecule, GMP, ICH, FDA, EMA, New Drug Application.
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Document control, archive, archival, archivist, doc control, qa, quality assurance, quality associate, quality specialist, quality assurance specialist, gmp, cgmp, gxp, mastercontrol, veeva vault, edms, document management system, pharma, biopharma, medical device, biotech, biotechnology, fda, quality systems, qms, eqms, clinical manufacturing, commercial manufacturing, novel pharmaceutical, novel drug, novel therapeutic.
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Proven track record of successfully leading teams in the development of robust analytical assays in regulated GMP/GxP environments and working knowledge of relevant cGMP/ICH/FDA/EU regulations.
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Experience in FDA pre-approval inspections and GMP inspections is a plus. Monitor, track, and trend stability data and GMP quality systems and establish metrics. We have acquired two FDA approved non-opioid pain products, GLOPERBA and ELYXYBTM, for the treatment of gout in adults and oral solution for the acute treatment of migraine, with or without aura, in adults.
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Gmp, Haccp, Fda, Sop, Food safety, Food manufacturing, Sanitation, Cleaning, Sanitizing, Chemical, Food production, Food industry. Gmp,Haccp,Fda,Sop,Food safety,Food manufacturing,Sanitation.
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The role oversees and manages the Development QA team and interacts cross-functionally with functional teams who interact with and/or support Preclinical and Clinical Trials, which include Preclinical and Clinical Operations; and, Product Development, GMP teams, Pharmacovigilance, Medical Writing, Biostatistics and Data Management to ensures compliance to the Quality Management System (QMS) and all applicable regulatory requirements.
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Work in a GMP analytical laboratory involved with FDA testing (food packaging and pharmaceuticals) Maintain current expertise with all appropriate ICH, GMP, and FDA guidelines.
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Understanding of regulatory requirements in GMP (Good Manufacturing Practice), such as FDA regulations for pharmaceutical manufacturing. Ensure MES system is in compliance with industry-specific regulations, such as FDA guidelines and GMP requirements, Lilly corporate policy and procedures, and local procedures to maintain product quality and safety.
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HACCP, FSMA, GFSI, FSSC, OSHA, GMP, FDA, BRC, SQF, USDA, and AIB audit knowledge. SQF Practitioner with PCQI Certification preferred. HACCP, FSMA, GFSI, FSSC, OSHA, GMP, FDA, BRC, SQF, USDA, and AIB audit knowledge.
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Familiar with FDA regulations, GMP, BRC/SQF, and OSHA safety regulations. Volt is immediately hiring for a Continuous Improvement Manager- Bilingual (English/Spanish) in Bartlett, IL for a growing food products supplier.
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Develop, implement, and maintain GMP quality management systems, policies, and SOP. Support PAI and GMP inspections at CMO and/or CDMO. Experience in GMP manufacturing for commercial products and/or late stage/Phase 3 clinical pipeline is a must.
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E.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. Extensive working knowledge of FDA regulations, FDA guidance and ICH guidance; some familiarity exposure to EMEA regulations.
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