QA Specialist - Compliance - Natural Organics Inc

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

1) Review of product formulations and labels (and revisions thereof) for compliance with established guidelines and regulations. Support the issuance of compliant Master Manufacturing Records (MMRs) and Master Packaging Records (MPRs), in the correct format, to production requirements, and for the generation issuance of batch records, for execution in production.

2) Prepare compliant product specific White Paper documentation for each product developed by and manufactured at NOI. This includes outlining all testing performed for each product, providing written justification for each product's testing scheme, and coordination of document approval.

3) As directed shall create, review, issue, and/or maintain, for compliance to regulatory requirements, other Quality and Operational documentation generated at the site. This may include documents such as, but not limited to, validation protocols, audit records, equipment/instrument manuals, calibration and maintenance records, certificates of ingredients, label copy, and formulations.

6) Provide quality and regulatory related support to all departments to ensure that Standard Operating Procedures required for cGMP compliance are created, reviewed, issued, revised, and maintained in accordance to company procedures and policies.

7) Maintain, as per company procedures and policies, SAP, ETQ, and Formulator systems as they relate to the responsibilities herein.

Physical Requirements:

Standing and walking short distances for most of the day

Must be able to lift 10 lbs.

Qualifications:

Bachelors Degree in Pharmacy, Chemistry, or other related field

Masters Degree in Pharmacy, Chemistry, or other related field or 10+ years working directly in Pharmaceutical, Dietary or Nutritional Supplement, or a similar cGMP related industry.

Strong Documentation and Computer Application ability required.

Strong written and oral communication skills required.

Must be detail oriented and well organized.