Compliance Specialist III

Job Description

Duties & Responsibilities:

• Perform audits necessary to ensure the compliance of manufacturing procedures to in-house specifications and government regulation.
• Establish auditing requirements, quality standards and test methods in accordance with regulations and relevant quality requirements.
• Conduct internal audits of manufacturing processes to ensure compliance.
• Review document and complete inspection of returned goods.
• Interpret complex, explicit documentation to ensure quality standards and compliance.
• Work under only very general supervision.
• Work is reviewed for soundness of judgment and overall adequacy and accuracy.
• Contribute 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.
• Represent organization on specific projects.

Required Skills & Experience:

• 6–9 years of relevant QA / Compliance experience required Auditing experience required, including manufacturing process audits.
• HS Diploma is acceptable with strong experience.
• If closer to 6 years, Associate’s or Bachelor’s preferred.
• Strong GMP manufacturing QA background Experience with batch release / finished product inspection.