The QA Associate ensures compliance with GMP standards, established procedures, documentation accuracy, product quality, and regulatory requirements. The role involves close collaboration with production and warehouse teams to maintain control over materials, batch records, retains, and documentation while ensuring operational readiness for audits and inspections.
Responsibilities:
· Maintain an active QA presence on the line, ensuring compliance with GMP, company SOPs, and Health Canada regulations.
· Perform and document line clearances before batch start-up, product, or flavour changeovers.
· Conduct continuous in-process checks (e.g., pouch weight, seal integrity, count accuracy) and record findings in real time.
· Quantify and document rejects and yield losses and reconcile them with batch records.
· Immediately report any deviations, mix-ups, or nonconformances and assist in preliminary impact assessments.
· Ensure all batch records are accurately filled out in real time and signed by responsible personnel.
· Control issuance and reconciliation of batch records, labels, and QA-controlled documents.
· Verify and approve production labels prior to use, ensuring correct product strength and flavor identification.
· Log and maintain retain samples, ensuring proper labelling, storage, documentation, and chain of custody.
· Ensure correct material status (e.g., QA hold, released) and traceability during dispensing and production.
· Receive incoming raw materials; verify identity, label integrity, documentation, and match with Certificates of Analysis (CoA).
· Enforce GMP and hygiene practices on the floor; ensure personnel follow gowning, cleaning, and behavior protocols.
· Support audit readiness and inspection requirements; participate in internal inspections and ensure production areas remain audit ready.
· Identify potential compliance risks or procedural gaps and report them to QA management.
· Assist in investigating deviations, OOS results, and customer complaints related to production or packaging operations.
· Contribute to continuous improvement initiatives and risk mitigation actions across QA and production.
· Perform other quality-related tasks as assigned by QA management.
Additional Requirements:
· Must be legally eligible to work in Canada.
· Flexible availability: able to work various shifts (days, nights, weekends, holidays) and be on-call when required, in accordance with Ontario’s Employment Standards Act (ESA).
· Willing to rotate across shifts as business needs require.
· Must have a valid driver’s license and access to a reliable vehicle for travel between sites.
· Detail-oriented, accountable, able to work independently, and responsive in a fast-paced production environment.
· Adheres to all health and safety practices under the Occupational Health and Safety Act (OHSA).
Physical and Environmental Conditions:
· Must be able to work in continental shifts.
· This role requires standing and walking for extended periods on the production floor.
· Tolerant of strong flavour/odor environments and comfortable wearing respirators and other PPE for full shift durations.
· Employee must be capable of lifting materials up to 20 kg.
· Production areas may operate at varying noise levels; hearing protection is provided when required.
· Work is performed in temperature-controlled environments with frequent interaction between production and warehouse areas.
Qualifications:
· Bachelor’s degree or diploma in Science, Pharmacy, or a related field.
· 1–2 years of experience in a GMP-regulated environment (pharmaceutical or nutraceutical).
· Working knowledge of GMP, GDP, and quality systems (deviation, CAPA, change control).
· Strong analytical and critical thinking skills.
· Good communication skills, both written and verbal.
· Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Job Types: Full-time, Permanent
Pay: $23.00-$25.00 per hour
Benefits:
- Dental care
- On-site parking
- Vision care
Education:
- Bachelor's Degree (required)
Experience:
- Pharmaceutical manufacturing: 1 year (preferred)
Work Location: In person
