Shop-Floor QA SME
- Toronto, ON, Canada
Contract
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Job details
- Job type
- Contract
- Apply by
- Posting language
- English
- Posted
Original job description
Role overview
Embedded QA professional providing routine quality presence on the manufacturing and packaging floor. Strengthens real-time oversight, cGMP behaviors and batch documentation quality during the remediation program.
Key responsibilities
- Provide daily QA presence on manufacturing and packaging lines
- Verify clean equipment and room status; oversee line clearance and batch start-up
- Support batch record review and correct documentation issues at source
- Coach operators on cGMP behaviors and good documentation practice (ALCOA+)
- Identify, escalate and trend floor-level events; support human-error reduction actions
- Contribute to cleaning and line-clearance procedure updates and floor-level training
Mandatory requirements
- 5+ years of GMP manufacturing QA with direct shop-floor support
- Experience with batch record review, line clearance and in-process QA checks
- Strong working knowledge of good documentation practice and data integrity on the floor
- Able to work on-site full time, including flexible shift coverage when approved
Plus the common requirements listed on page 1.
Preferred qualifications
- Solid oral dosage (tableting, encapsulation, coating) and/or packaging experience
- Experience in sites under regulatory remediation
- Experience with electronic batch records and MES
More about this job
Responsibilities
Provide daily quality assurance oversight on manufacturing and packaging lines, verifying equipment and room readiness, line clearance, batch start-up, and batch documentation. Coach operators on cGMP and good documentation practices, escalate and trend floor-level events, and support procedure updates, training, and human-error reduction.
Requirements
Requires at least five years of GMP manufacturing quality assurance experience with direct shop-floor support, including batch record review, line clearance, and in-process checks. Candidates must have strong knowledge of good documentation practices and floor-level data integrity, and be able to work on-site full time with approved flexible shift coverage; oral dosage, remediation, and electronic batch record or MES experience are preferred.
Skills
- GMP Manufacturing Quality Assurance
- Shop-Floor Quality Assurance
- Batch Record Review
- Line Clearance
- In-Process Quality Checks
- Good Documentation Practice
- Data Integrity
- cGMP Compliance
- ALCOA+
- Equipment and Room Status Verification
- Batch Start-Up Oversight
- Event Escalation and Trending
- Human-Error Reduction
- Cleaning Procedure Updates
- Floor-Level Training
- Electronic Batch Records and MES
Visa sponsorship
Not detected in the job text
Categories
- Manufacturing
- Healthcare
- Management & Leadership
Keywords
- GMP
- cGMP
- Manufacturing
- Packaging
- Quality Assurance
- Shop-Floor Oversight
- Batch Records
- Batch Record Review
- Line Clearance
- In-Process Quality Checks
- Good Documentation Practice
- ALCOA+
- Data Integrity
- Equipment Status
- Room Status
- Batch Start-Up
- Event Escalation
- Event Trending
- Human-Error Reduction
- Cleaning Procedures
- Operator Coaching
- Floor-Level Training
- Oral Dosage
- Tableting
- Encapsulation
- Coating
- Regulatory Remediation
- Electronic Batch Records
- MES