Performs audits necessary to ensure the compliance of manufacturing procedures to in-house specifications and government regulation. Establishes auditing requirements, quality standards and test methods in accordance with FDA and GMP requirements. Conducts internal audits of manufacturing processes to ensure compliance. Conducts review of testing results. Reviews document and completes inspection of returned goods. May be involved with establishing compliance requirements for the methodology transfer from Research to Quality Control. Interprets complex, explicit documentation to ensure quality standards and compliance. May provide training to new employees. Works under only very general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy. Contributes to the completion of organizational projects and goals. Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify. Frequent internal company and external contacts. Represents organization on specific projects. Experience: 6 to 9 years. Knowledge of government contract execution and compliance with the federal acquisition regulations (FARs). Skills: 1. The ability to coordinate multiple priorities in a fast paced environment 2. Solid organizational, analytical and problem solving skills 3. Strong attention to detail and able to work independently 4. Strong communication skills with the ability to interact with all levels throughout the organization 5. In addition, demonstrated excellent interpersonal skills and flexibility Education: Minimum of a B.S. in Biology, Chemistry, Microbiology or related field
Compliance Specialist III • Rockville, MD, United States
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