Primary Duties and Responsibilities Support Quality Control departments in duties including but not limited to: Conduct Analysis in compliance with cGMP requirements, compendia standards, and internal procedures. Performs Dietary supplement analysis to support manufacturing which includes instrumental and physical testing. Maintain accurate record of analysis and perform documentation to company standards. Perform laboratory analysis right the first time and document the results contemporaneously. Notify the manager immediately of nonconforming data or unexpected occurrences. Reviews and analyzes the stability samples and associated analytical data, prepares or assists in preparing Stability Summary Reports. Reviews/Checks of analytical data by following test methods/SOPs. Conducts laboratory investigation under the supervision of laboratory management. Organize work schedule to complete assigned tasks efficiently and on schedule. Ensures the laboratory is kept in a safe working environment and compliance with OSHA and other laboratory safety standards. Ensure and maintain retained samples. Pulling of samples. Organization of retaining cages. Oversight and Inspect production lines throughout the production run. Helping to eliminate errors/ Line Clearance Test and monitor the facility's environment for microbial contaminants. Water system, Air monitoring, Drains, Hoses and Sinks, Inspect, test, and release cleaned equipment Working closely with sanitation personnel Maintain the trending of data/results generated from the environmental monitoring and cleaning equipment verifications. Maintain laboratory equipment and assist in ordering laboratory supplies. Reagents, Microbiology media, Lab utensils, etc. Testing of raw materials, components, finished products, and stability. Send appropriate samples to 3rd party laboratories. Ensure lab testing is being conducted properly. Statistical sampling plans. Update laboratory reagents/chemicals list as needed. Write and revise Standard Operating Procedures, testing specifications, protocols, and reports as needed. Record all data and results in specified forms, record books or logbooks with accuracy. Assist with filing documents. Assist with cleaning/method validation studies. Locate opportunities for continuous improvement. Other duties as assigned by Quality Management. Travel required: approximately 10% between different locations Qualifications Qualifications include: Associate's degree in science-related field 2-5 years experience in FDA-regulated Pharmaceutical, Nutraceuticals or the Food industry Basic knowledge of Microsoft Office Keen eye for detail Ability to work closely with co-workers Effective communication skills Strong problem-solving/troubleshooting skills Ability to multi-task in a fast-paced environment Organizational skills
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