Coordinates and performs the responsibilities of the Quality Assurance Raw Materials Program (QAR) including; receipt, storage, inspection, sampling, testing and disposition of materials. Assists in the preparation of Standard Operating Procedures (SOPs). Assists in the documentation of Non-conforming events (NCEs). Reviews laboratory test data and performs inspections in accordance with current Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), for nonclinical laboratory studies and Points to Consider (PTC) guidelines.
• Performs daily activities for QAR and maintains and continually aids in building QA Raw Material Systems. • Performs physical inspection of raw material containers upon receipt to ensure the correct items ordered were delivered and were not damaged during shipping. • Samples raw materials for release during testing, as necessary. • Performs inspection and ensures proper testing of raw materials is performed in accordance with release procedures. • Reviews inspection and testing data and directs disposition of materials after all release criteria have been evaluated. • Prepares and distributes certificates of analysis/conformance as required. Participates directly in audits of assigned areas. • Inspects in-house areas, discusses conditions/practices with appropriate personnel, documents and reports findings to Management and follows-up as needed. • Conducts the reviews of raw data, batch records and test results, in accordance with cGMP, GLP, Code of Federal Regulations (CFR), Points to Consider (PTC) guidelines and internal procedures in an efficient and timely manner. • May be required to work overtime.
• 3 -5 years of relevant experience or equivalent • High School diploma or equivalent required, Bachelors' degree in a Science related field preferred or equivalent experience
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