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QC Chemist will perform, under the direct supervision of the Director of QA/QC, inspection and analysis on raw materials, in-process samples, and finished goods to ensure compliance with cGMP/GLP/ISO standard operating procedures.
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Nature & Scope:QC Chemist will perform, under the direct supervision of the Director of QA/QC, inspection and analysis on raw materials, in-process samples, and finished goods to ensure compliance with cGMP/GLP/ISO standard operating procedures.
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2-3 years' work experience preferably in a cGMP Facility for dietary supplements. 2-3 years' work experience preferably in a cGMP Facility for dietary supplements. Utilizes powered cleaning equipment that may include lift truck, scissors lift, power washer, foam applicators, automatic compactors and various non-mechanized equipment.
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Prefer cGMP pharmaceutical industry, biologics industry experience; medical device or tissue processing industries considered. In this exciting role as an Validation Senior Quality Engineer, you will design or plan protocols for equipment or processes to produce tissue-based products, biologic drug products and medical device products meeting internal and external purity, safety and quality requirements.
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Overlook and participate change approval process for risk assessment, verification, and validation. Leads product quality investigations in support of CAPA, complaints and nonconforming material processes.
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Direct key personnel in donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP.
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Inspect and analyze raw materials, in-process samples, and finished goods in accordance with cGMP/GLP standard operating procedures. QC Chemist - Kennesaw, GA. Experience with any of the following: standard assay procedures, IR, HPLC, PCR, Real-Time PCR.
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Maintains thorough familiarity and ensures compliance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP.
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CGTP, cGMP, HCT/P Final Guidance on Minimal Manipulation and Homologous Use, regulatory submissions, regulated product marketing and labeling, clinical trials, and other applicable state, federal, or international regulations.
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Ensure compliance with cGMP regulations, guidelines, and safety procedures. Experience with PCR, RT-PCR, Microbial plating, OR ELISA is preferred. Rapidly Growing global human and animal nutrition company is seeking an Analytical Laboratory Technician for their 1st shift to work on research driven projects.
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Quality Control and knowledge of cGMP. Experience with any of the following: PCR, Real-Time PCR, Microbial plating, ELISA, SDS-Page. Perform a variety of laboratory techniques and/or protocols for Analytical Chemistry / Quality Control / Quality Assurance.
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Rapidly Growing global human and animal nutrition company is seeking an Analytical Laboratory Technician for their 1. Bachelors degree in Biology, Microbiology or other science w/ academic lab experience required.
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