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Posted 13 days ago

Shop-Floor QA SME

@ United Pharma

Toronto, Ontario

Contract
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SIGNALS

Requirements summary:

  • Mandatory requirements
  • 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
  • Plus the common requirements listed on page 1.
  • Preferred qualifications
  • Solid oral dosage (tableting, encapsulation, coating) and/or packaging experience
Source and dates

Source type not verified · apify-linkedin

Employer posting date
2026-10-28
First seen by our source
2026-11-11
Source record updated
2026-11-11

These dates describe the source record, not a live verification that the employer is still hiring. Check the original posting.

United Pharma

FieldValue
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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

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