QA Documentation Associate

2 weeks ago

Barrie ON LN J, Canada HK Kolmar Canada Full time

GENERAL DESCRIPTION:

The Quality Assurance (QA) Documentation Associate is responsible for ensuring that all manufacturing and quality documentation complies with Good Manufacturing Practices (GMP), Drug Identification Number (DIN), and Natural Health Product (NHP) regulations. This role involves thorough document review, compliance verification, and supporting product release activities in a regulated facility. The position requires strong attention to detail, regulatory knowledge, and collaboration with cross-functional teams to ensure high-quality standards are maintained.

DUTIES/RESPONSIBILITIES:

  • Conduct detailed review of batch manufacturing records, batch packaging records, and laboratory test results to ensure completeness and compliance with GMP, DIN, and NHP regulations.
  • Verify that all critical process parameters, in-process controls, and finished product specifications meet established quality standards.
  • Ensure all deviations, non-conformances, and out-of-specification (OOS) results are properly investigated, documented, and closed before batch release.
  • Approve and release finished products for distribution, ensuring all release criteria are met.
  • Approve and release finished products within Customer portals.
  • Ensure batch, quality assurance and production documentation are complete and accurate and verify against load slips.
  • Ensure proper filing and archival of completed batch records and reports.
  • Release product in HK Kolmar ERP system (Deacom) once release criteria are met.
  • Prepare and send customer documentation packages, including copies of documents such as formulae, procedures and specifications.
  • Create Certificates of Analysis and Manufacture as required and distribute as per customer protocols
  • Maintain updated Distribution List and Certificate database

Comply with Good Manufacturing Practices, Standard Operating Procedures and Safety Standards and follow plant policies and procedures.

QUALIFICATION REQUIREMENTS:

Education/Experience:

  • B.Sc. in one of the Sciences; Computer competency required. SPC and Quality Principles an asset.
  • Minimum 2 years experience related field

Skills/Knowledge/Licences:

  • Keep updated on current Industry, Governmental and Regulatory standards and initiatives
  • Ability to deal well with customers, especially under pressure.
  • High energy
  • An in-depth understanding of what the customer requirements, balanced against what we are able to provide.

Job Types: Full-time, Permanent

Pay: From $20.00 per hour

Expected hours: 40 per week

Benefits:

  • Company events
  • Dental care
  • Disability insurance
  • Employee assistance program
  • Life insurance
  • On-site parking
  • Vision care

Work Location: In person

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