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About the Role

The Quality Assurance Specialist - Compliance is responsible for helping to ensure that NOI has in place procedures and processes that are followed to ensure compliance with CGMP and HACCP requirements and regulations.

Responsibilities

• Review product formulations and labels for compliance with guidelines and regulations.
• Support the issuance of compliant Master Manufacturing Records (MMRs) and Master Packaging Records (MPRs).
• Prepare compliant product specific White Paper documentation, outlining testing performed and providing justification.
• Coordinate document approval for White Papers.
• Create, review, issue, and/or maintain other Quality and Operational documentation for regulatory compliance.
• Provide quality and regulatory support to ensure Standard Operating Procedures (SOPs) are created, reviewed, issued, revised, and maintained.
• Maintain SAP, ETQ, and Formulator systems as they relate to quality assurance responsibilities.

Requirements

• Strong Documentation and Computer Application ability required.
• Strong written and oral communication skills required.
• Must be detail oriented and well organized.
• Standing and walking short distances for most of the day.
• Must be able to lift 10 lbs.

Skills

• Documentation
• Computer Applications
• Written Communication
• Oral Communication
• Detail Oriented
• Organization

Experience Level

• 10+ years working directly in Pharmaceutical, Dietary or Nutritional Supplement, or a similar cGMP related industry (with Masters Degree)

Education Level

• Bachelors Degree in Pharmacy, Chemistry, or other related field
• Masters Degree in Pharmacy, Chemistry, or other related field