Job Title: Shop-Floor Quality Assurance (QA) SME
Industry: Pharmaceutical / Biotechnology
Job Type: Contract
Location: Greater Toronto Area (GTA), Ontario, Canada
Work Arrangement: On-site
Experience: 5+ Years
Duration: 12+ Months, with possible extension
Job Summary:
We are seeking an experienced Shop-Floor Quality Assurance (QA) SME to provide hands-on quality oversight across pharmaceutical manufacturing and packaging operations. The ideal candidate will ensure compliance with current Good Manufacturing Practices (cGMP), maintain accurate batch documentation, verify equipment and production area readiness, and support quality improvement initiatives.
The candidate will work closely with Manufacturing, Packaging, and Quality teams to identify and resolve quality issues, improve documentation practices, support deviation investigations, and maintain inspection readiness. This role requires strong knowledge of pharmaceutical quality systems, manufacturing processes, and regulatory requirements.
Key Responsibilities:
Shop-Floor Quality Oversight: Provide daily QA support on the manufacturing and packaging floors to ensure compliance with approved procedures and GMP requirements.
Line Clearance and Equipment Verification: Perform line clearance checks and verify equipment cleanliness, room readiness, and equipment status before production activities.
Batch Record Review: Review batch manufacturing and packaging records, identify documentation errors, and ensure discrepancies are addressed promptly.
GMP Compliance: Ensure manufacturing activities comply with cGMP requirements, approved procedures, and applicable regulatory guidelines.
Documentation and Data Integrity: Reinforce good documentation practices (GDP) and ALCOA+ principles to maintain accurate, complete, and reliable production records.
Deviation Management: Identify, document, and escalate deviations, quality events, and recurring compliance issues. Support investigations and corrective and preventive actions (CAPA).
Operator Training: Train and coach production personnel on GMP requirements, documentation standards, line clearance, and quality procedures.
Quality Improvement: Support initiatives to reduce human errors, prevent documentation mistakes, and improve shop-floor compliance.
Procedure Management: Assist in reviewing and updating cleaning procedures, line clearance procedures, standard operating procedures (SOPs), and work instructions.
Inspection Readiness: Maintain manufacturing areas and quality documentation in an inspection-ready state for Health Canada and FDA inspections.
Cross-Functional Collaboration: Work with QA, Manufacturing, Packaging, and other departments to resolve quality issues and ensure smooth production operations.
Quality Records Management: Prepare, review, and close quality records and related documentation in accordance with established procedures and regulatory requirements.
Required Skills:
- Minimum 5+ years of experience in pharmaceutical Quality Assurance, with direct shop-floor manufacturing support.
- Strong knowledge of cGMP requirements and pharmaceutical manufacturing processes.
- Hands-on experience with batch record review, line clearance, equipment cleanliness verification, and in-process quality checks.
- Knowledge of Good Documentation Practices (GDP) and ALCOA+ data integrity principles.
- Experience with deviation reporting, investigations, CAPA, and quality event management.
- Familiarity with Health Canada GMP requirements and FDA 21 CFR Parts 210, 211, and 11.
- Understanding of Health Canada Food and Drug Regulations, Part C, Division 2, and GMP Guide GUI-0001.
- Knowledge of ICH Q7, Q9, and Q10 and relevant PIC/S GMP guidance.
- Ability to identify quality risks and resolve documentation issues in a manufacturing environment.
- Strong written and verbal communication skills.
- Excellent attention to detail, problem-solving, and organizational skills.
- Ability to work full-time on-site in the Greater Toronto Area and provide flexible shift coverage as required.
- Must be legally authorized to work in Canada.
- Willingness to complete background checks and required site-access training.
