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Understanding of food safety principles, SOPs, cGMP, HACCP, regulatory requirements, and quality standards Demonstrated competent writing abilities. Full competent and proficient on updated cGMP, industry standards, FDA regulations, and best practices in manufacturing and quality control.
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The QA Documentation Control Specialist II is responsible for the maintenance of the cGMP controlled documentation system and for providing the various client departments the documentation that is necessary to perform cGxP activities.
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Responsibilities: This position manufactures bulk API products primarily related to the following product classifications: Opiates Biopharmaceutical Other Controlled Substances Sets-up, operates, and cleans production equipment, completes batch records, maintains a clean and safe operating area, ensures batch quality and integrity, troubleshoots problems, and meets production schedules in accordance with FDA and Current Good Manufacturing Practices (cGMP) guidelines.
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This position is 3rd Shift, 6PM – 2:30AM II: Essential Functions Comply with cGMP regulations, adhere to company policies, and adhere to SOP and Batch Record directions Assist the Validation with the operation and execution of engineering projects.
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Performs document control functions to ensure the integrity of all Stability and QC Laboratory records in accordance with cGMP requirements. Minimum of 1-year hands-on experience supporting cGMP manufacturing environment.
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Learn and maintain thorough familiarity and compliance with all state and federal regulations, Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), and internal Company Procedures.
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Ability to maintain 100% compliance in all SOP, cGMP, EHS and other training curriculum as assigned. Ø Ability to follow cGMP and other regulatory requirements. Prefer previous experience in a manufacturing environment within pharmaceutical, nutraceutical or food processing industries.
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Familiarity with general chemistry, mathematics, microbiology and cGMP clean room operations is a plus. Ensures compliance with cGMP and safety requirements. Familiarity with general chemistry, mathematics, microbiology and cGMP clean room operations is a plus.
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Actively licensed or certified in the state where performing duties: Licensed Practical Nurses (LPN), Licensed Vocational Nurses (LVN), Nurse Licensure Compact (NLC) Determine donor eligibility by performing donor eligibility assessments, to include; medical history interview, physical examination, educating donor on donor testing, HIV/AIDS virus, donation risks, informed consent, confidential self-exclusion, and reviewing Serological Protein Electrophoresis (SPE) testing as necessary.
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Follow all standard operating procedures for all medical emergencies, to include communication with the Center Medical Director and donor transport to emergency medical care facilities. Licensed Vocational Nurse.
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Knowledge of codes, standards and guidelines as related to labs, individual municipalities, State, IBC, ADA, ANSI, NFPA, NSF, cGMP and cGLP required. Knowledge of codes, standards and guidelines as related to labs, individual municipalities, State, IBC, ADA, ANSI, NFPA, NSF, cGMP and cGLP required.
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Preferred:Good understanding and exposure to current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirementsThorough understanding of and experience with some aspect of technical operations; interest and demonstrated ability to learn across several disciplines (manufacturing, quality, supply chain, technical development, regulatory, patient experience, finance, operations, etc.
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Complete and remain current with all required cGMP and safety training. Job Details This position is responsible for the following: Perform tasks in the production/packaging of product to provide on-time delivery to customers.
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Expert knowledge in compendial testing, cGMPs, ICH, FDA regulations, and FDA Guidance with strong understanding of cGMP regulations for pharmaceutical and/or food industry. Must have at least 7 years’ experience in analytical laboratory environment within a cGMP facility.
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Cogmedix.com. The Assembly Tech I will perform assembly processes on a variety of complex electro-mechanical and optically based sub-assemblies and finished medical devices while following Current Good Manufacturing Practices (cGMP.
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