Review batch production and packaging records for completeness, accuracy, discrepancies, and GMP compliance; provide backup batch disposition/release support only within documented training and delegated authorization.

Company Overview The Quality Assurance Specialist supports HK Kolmar Canada’s Quality operations through GMP compliance, audit readiness, quality systems documentation, and review of laboratory and manufacturing records. The position supports internal, customer, and regulatory audits; prepares,

reviews, and follows up on deviation investigation reports (DIRs), corrective and preventive actions (CAPAs), and change controls; and provides supplementary QC data review and backup batch disposition/release support when trained and formally authorized. The Specialist works across

Quality Control, Manufacturing, Technical Services, and other departments to ensure records are accurate, complete, timely, and compliant with internal, customer, and applicable regulatory requirements. The position also receives cross-training and provides support for Regulatory Affairs activities, including preparation, submission, and tracking of product licensing, registration, artwork, labeling, and related regulatory documentation under appropriate oversight.

DUTIES & RESPONSIBILITIES:

- Support preparation, coordination, and follow-up for customer and regulatory GMP audits, including documentation requests, audit evidence, observation responses, and action tracking.
- Plan, conduct, and document internal GMP audits and facility inspections to assess compliance with approved procedures, GMP, GDP, and applicable regulatory requirements; identify and report observations, coordinate corrective actions, and verify timely follow-up and closure.
- Prepare, review, and support investigations of deviations and nonconformances (DIRs), including documented impact assessments, root cause analysis, and appropriate corrective actions.
- Author, coordinate, and monitor CAPAs, including action plans, assigned owners, due dates, supporting evidence, and effectiveness checks.
- Support change control initiation, documentation, risk/impact assessment, implementation tracking, and closure in accordance with approved procedures.
- Receive training and provide support and backup coverage for Regulatory Affairs activities,



as assigned and within documented training and authorization.
- Assist with preparation, review, submission, and maintenance of product licence applications, registrations, notifications, renewals, amendments, and related regulatory filings to Health Canada (including Natural Health Products) and the U.S. FDA, as applicable.
- Support preparation, review, and submission of product artwork, labels, and associated documentation to regulatory authorities, as required, in coordination with Regulatory Affairs and internal stakeholders.
- Maintain accurate regulatory submission trackers and records, including submission dates, status, agency correspondence, approvals, renewals, deadlines, and outstanding follow-up actions; escalate risks to timelines or compliance.
- Perform supplemental review and verification of QC analytical and microbiological records, instrument reports, calculations, logbooks, and other test data, including data integrity and traceability requirements.
- Identify, document, escalate, and coordinate resolution of OOS/OOT results, discrepancies, and quality events in accordance with applicable procedures.
- Assist with SOPs, forms, quality system documentation, training materials, and continuous improvement initiatives.
- Maintain clear quality event records and support timely completion of deliverables while coordinating priorities with cross-functional teams.
- Communicate effectively with internal stakeholders and external customers as required; support inspection readiness and retrieval of controlled documentation.
- Comply with GMP, Valuable Documentation Practices (GDP), data integrity requirements, applicable SOPs, and company policies.
- Support coordination and distribution of laboratory samples and associated documentation, as needed, to meet operational priorities and turnaround times.
- Provide backup support for review and maintenance of raw material documentation, certificates of analysis,



specifications, and related records, where trained and assigned.
- Support review and disposition of raw materials and customer-supplied bulks in applicable ERP systems, only when trained and formally authorized.
- Provide cross-training and backup support for other Quality functions where qualified and authorized.

QUALIFICATIONS:

Education

- Bachelor of Science degree with a major in Chemistry or related field

Experience:
- Working knowledge of GMP, GDP, data integrity principles, and applicable Health Canada/FDA requirements
- Familiarity with Health Canada and FDA product licensing, registration, labeling, or regulatory submission processes is an asset; training will be provided.
- Familiarity with incoming material/product handling, testing, and documentation processes.
- Experience in a GMP-regulated pharmaceutical, OTC, natural health product, cosmetic, or related manufacturing environment preferred
- Experience with batch record review, quality investigations, audit support, and quality systems (CAPA/change control) is an asset
- Experience with ERP and/or document control systems.

Skills/Abilities:
- Fully knowledgeable on Good Manufacturing and Good Documentation Practices
- Strong technical writing, investigation, organization, and follow-up skills; ability to work across departments
- Proficiency with Microsoft Office; experience with ERP systems is an asset
- Highly organized with strong attention to detail.
- Good oral and written communication skills.
- Computer competency required.
- Ability to work independently in fast paced production environment.

This job specification should not be interpreted as the exclusive requirements and standards of the position. It is expected that all instructions will be followed, and any other duties requested will be performed as required. HK Kolmar Canada Inc. is committed to providing an accessible recruitment process. Accommodations are available upon request throughout the recruitment and selection process. Please contact Human Resources to request an accommodation.

Pay: From $25.00 per hour

Benefits

- Company pension
- Dental care
- Employee assistance program
- Extended health care
- In office parking
- Vision care

Work Location: In person

📌 Quality Assurance Specialist (Barrie)
🏢 HK Kolmar Canada
📍 Barrie