Quality Assurance Technician

2 months ago

Winnipeg, Manitoba, Canada Emergent BioSolutions Inc. Full time

Job Summary

Fosters a culture of continuous improvement and operational excellence in a regulated environment. Assumes leadership responsibilities when the supervisor is not present. Coordinates manufacturing, environmental monitoring, and equipment/facility cleaning/sanitization in a cGMP environment. Qualified trainer for manufacturing processes.

Key Responsibilities

  • Identifies and champions process improvement initiatives.
  • Assumes shift leadership role in the absence of the supervisor, directing the activities of other manufacturing technicians to meet production schedule requirements.
  • Designs and conducts manufacturing process studies, reporting on findings.
  • Participates in cross-functional project teams.
  • Leads and contributes to the implementation of routine and complex process improvement, document, and change initiatives.
  • Demonstrated proficiency in quality systems:
    • Performs root cause analysis to investigate manufacturing deviations.
    • Initiates and authors Standard Operating Procedures and Batch Production Records.
    • Coordinates corrective actions/preventative actions.
  • Reviews documentation for accuracy and completeness.
  • Qualified trainer for manufacturing process execution:
    • Adaptable to the learning style of the trainee.
    • Gives timely and candid performance feedback.
    • Coordinates training and progression plans for assistant and technician-level employees.
  • Maintains training/competence on technician and lead technician-level job tasks and executes as required.
  • Executes and documents procedural steps in compliance with cGMP standards, clean room behavior, and aseptic technique Standard Operating Procedures.
  • Maintains facility environmental control, including preparation of cleaning solutions, daily, monthly, quarterly, and annual cleaning of manufacturing surfaces and equipment.
  • Performs daily assignments with minimal to no supervision.
  • Coordinates with quality for straightforward manufacturing hurdles or provides a list of potential actions to remediate the issue for supervisor/manager decision.

Requirements

  • High school diploma or equivalent required; pharmaceutical manufacturing diploma or bachelor's degree in science/engineering considered an asset.
  • Minimum of 4 years of related experience required; previous experience working in a regulated environment required.
  • Knowledge of cGMP and CFR requirements.
  • Ownership – Actively participates in self-development.
  • Accountability – Follows through on commitments.
  • Detail-oriented – Able to complete required tasks and associated documentation with minimal error.
  • Adaptability – Maintains a positive attitude in a changing work environment.
  • Communication – Effectively communicates with all levels of manufacturing and support staff.
  • Participates in department/level meetings.
  • Escalates issues through proper channels.
  • Able to work on ladders or at heights when required.
  • Ability to lift and move materials/equipment when needed.
  • Ability to pass a pre-employment medical and criminal background check.
  • Ability to adapt to and complete shift work, including days, evenings, and nights.
  • This role requires the removal of all jewelry, wristwatches, makeup, and any other non-essential items as per gowning requirements.

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