Compliance Specialist II

Job Description

Duties and 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.
• Conduct review of testing results.
• Review document and complete inspection of returned goods.
• May be involved with establishing compliance requirements for the methodology transfer from Research to Quality Control.
• Interpret complex, explicit documentation to ensure quality standards and compliance.
• May provide training to new employees.
• 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.

Education:

• Bachelors Degree.

Experience:

• 3 – 6 Years of experience.
• SAP experience, managing complaint or complaint investigation, or experience acquiring data in LIMS, Veeva.
• Minimum of 2 years of experience in GMP, can be in quality, manufacturing.
• Must have inspection experience process, must have previous experience inspection of in process and finished goods.
• Previous pharma experience.
• Experience investigating and experience with deviations.