QA Specialist - Compliance

Natural OrganicsAmityville, NY
Onsite

About The Position

Natural Organics Inc., marketing products under the Natures Plus brand, is seeking a proactive, detail-oriented QA Specialist - Compliance for their Amityville location. This role is responsible for ensuring that procedures and processes are in place and followed to comply with cGMP and HAACP requirements and regulations. The company has been a leader in natural vitamins and supplements for over 50 years.

Requirements

  • Strong documentation and computer application ability required.
  • Strong written and oral communication skills required.
  • Must be detail oriented and well organized.

Nice To Haves

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

Responsibilities

  • 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.
  • 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.
  • 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.
  • Provide quality and regulatory related support to all departments to ensure that Standard Operating Procedures (SOPs) required for cGMP compliance are created, reviewed, issued, revised, and maintained in accordance to company procedures and policies.
  • Maintain, as per company procedures and policies, SAP, ETQ, and Formulator systems as they relate to the responsibilities herein.

Benefits

  • Competitive salary
  • Medical
  • Dental
  • Vision
  • Life Insurance
  • Aflac
  • Short- and Long-Term Disability
  • 401(k) with company match
  • Generous paid time off days and holidays
  • Opportunities for professional development and growth
  • Discounted vitamins and supplements
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