Shop-Floor Quality Assurance (QA) SME

Virtue America; Toronto; On-site; CAD 90,000 - 130,000; Full time

Job summary

Virtue America in Canada is seeking an experienced Shop-Floor Quality Assurance (QA) SME to provide hands-on quality oversight across pharmaceutical manufacturing and packaging operations.

The role ensures compliance with cGMP, maintains batch documentation, supports deviation investigations, and collaborates with Manufacturing, Packaging, and Quality teams to drive quality improvements and maintain inspection readiness for Health Canada and FDA.

Qualifications

• 5+ years in pharmaceutical Quality Assurance on the shop floor.
• Strong knowledge of cGMP requirements and pharmaceutical manufacturing processes.
• Hands-on experience with batch record review, line clearance, equipment cleanliness verification.
• Familiar with GDP and ALCOA+ data integrity principles.
• Experience with deviation reporting, investigations, CAPA, and quality event management.
• Knowledge of Health Canada GMP requirements and FDA 21 CFR Parts 210, 211, and 11.
• Understanding of regulatory guidance (ICH Q7/9/10) and PIC/S GMP guidance.

Responsibilities

• Provide daily QA support on the manufacturing and packaging floors to ensure GMP compliance.
• Perform line clearance checks and verify equipment readiness before production activities.
• Review batch manufacturing and packaging records and address discrepancies promptly.
• Ensure activities comply with cGMP requirements and regulatory guidelines.
• Reinforce GDP and ALCOA+ data integrity in records and systems.
• Identify, document, and elevate deviations; support investigations and CAPA.
• Train production personnel on GMP requirements and documentation standards.
• Maintain inspection readiness for Health Canada and FDA inspections.
• Collaborate across QA, Manufacturing, and Packaging to resolve quality issues.

Skills

cGMP knowledge

QA on shop floor

GDP & ALCOA+

Deviation investigations

CAPA handling

FDA/HC awareness

Line clearance

Documentation skills

Job description

Job Title: Shop-Floor Quality Assurance (QA) SME

Industry: Pharmaceutical / Biotechnology

Job Type: Contract

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 elevate 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.