Role Summary
The QC/QA Chemist is a core member of the Quality team responsible for ensuring that all raw materials, in-process samples, and finished products meet established specifications, regulatory requirements, and internal quality standards. This role operates within a GMP-compliant manufacturing environment and directly supports the company's Natural Product Number (NPN) licensing obligations under Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD).
The successful candidate brings a solid chemistry background, hands-on laboratory experience, and a thorough understanding of GMP documentation practices. Accuracy, regulatory awareness, and a commitment to quality culture are essential for this position.
Key Responsibilities
1. Quality Control Testing & Analysis
- Perform physical, chemical, and microbiological testing on raw materials, in-process samples, and finished products according to approved test methods.
- Conduct identity, purity, potency, and stability testing for NPN-licensed natural health products (NHPs).
- Operate and maintain laboratory instruments including HPLC, UV-Vis spectrophotometer, pH meters, Karl Fischer titrators, viscometers, and dissolution equipment.
- Prepare and standardize reagents, reference standards, and working solutions.
- Record all test results accurately and completely per GMP data integrity principles (ALCOA+).
2. GMP Documentation & Compliance
- Follow all Standard Operating Procedures (SOPs), work instructions, and GMP guidelines at all times.
- Author, review, and update SOPs, test methods, specifications, and batch records as required.
- Maintain instrument calibration logs, equipment logbooks, and laboratory housekeeping standards.
- Ensure all records meet Health Canada GMP documentation requirements (C.02.014–C.02.019).
- Complete all required GMP training and keep training records current.
3. NPN / Regulatory Support
- Provide analytical data and certificates of analysis (CoA) to support NPN product license applications and amendments.
- Interpret Health Canada's Natural Health Products Regulations (NHPR) and ensure testing aligns with NPN license conditions.
- Assist in maintaining site license and product license dossiers with current analytical data.
- Liaise with Regulatory Affairs to respond to Health Canada information requests related to product quality.
4. Raw Material & Supplier Qualification
- Review incoming raw material CoAs against approved specifications; release or reject materials accordingly.
- Perform incoming inspection testing per risk-based sampling plans.
- Support vendor qualification activities including review of supplier quality documentation.
5. OOS Investigations, Deviations & CAPA
- Identify, document, and investigate out-of-specification (OOS) and out-of-trend (OOT) results.
- Participate in root cause analysis (RCA) and corrective and preventive action (CAPA) processes.
- Report non-conformances and product defects to QA management in a timely manner.
6. Stability Program
- Execute and monitor ongoing and accelerated stability studies per ICH Q1A/Q1B guidelines.
- Compile and trend stability data; report findings to the QA Manager.
7. Audits & Inspections
- Support internal GMP audits and Health Canada inspections by preparing documentation and assisting with lab walkthroughs.
- Participate in mock inspections and audit readiness activities.
Pay: $21.00-$23.00 per hour
Education:
- Bachelor's Degree (required)
Experience:
- QC/QA: 5 years (required)
Work Location: In person
