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September 29, 2014
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Microbiology Laboratory Supervisor

Reference Number: 89
Location Pointe-Claire, Quebec
Reports To: Director of Quality Assurance/Quality Control
 
Description

Overall Job Summary:

The Microbiology Laboratory Supervisor is responsible for proper operation of microbiology laboratory.

Specific Accountabilities:

  • Responsible for the smooth operation of the microbiology lab.  This includes making decisions regarding timelines, personnel, sampling, testing, etc.
  • Responsible for the scheduling and follow-up of all laboratory work.  This includes: cleaning, qualification, validation, testing, instrument verification, etc.  As well as reviewing and approving related documentation.
  • Responsible for reviewing and approving certificate/reports of analysis for raw materials, packaging materials and waters.
  • Responsible for maintaining adequate supplies of lab materials needed.
  • Responsible for communicating important information to other departments/sites and liaising with Third-Party Laboratories
  • Responsible for performing trending of Environmental Monitoring results and related issues and reporting these to upper Management.
  • Responsible for performing trending of Water (Pure Steam, Water for Injection, Purified water, etc.) analysis results and related issues and reporting these to upper Management.
  • Responsible for conducting OOS investigations and issue Non-Conformance-Report as required
  • Responsible for conducting environmental-deviation-report investigations.
  • Responsible for troubleshooting of the equipment.
  • Responsible for reviewing and authoring documents such as SOP, WI, QCTM,etc., and ensuring they are in compliance with current regulations.
  • Responsible for validating/transferring testing methods and instruments (including development of Validation Protocols and reports and possibly execution of them).
  • Responsible for ensuring that that all testing is performed and recorded according to Bioniche and GLPs/GMPs requirements.
  • Responsible for reporting any major product quality problem and any safety/security issue to Manager promptly as they arise.
  • Responsible for acting as the Biosafety Officer for the Plant and performed all related tasks and responsibilities.

Education, Work Experience & Competencies

  • Minimum B.S. in Microbiology, Biology, or Biochemistry or relevant science discipline
  • 5 years of experience in QC laboratory in pharmaceutical or bio/pharmaceutical environment
  • 2 years of experience in a supervisory role
  • Must be Bilingual (English/French)
  • Deep knowledge of GMPs as they relate to laboratory work
  • Organizational/planning skills
  • Interpersonal and leadership skills and team spirit
  • Initiative and good judgment (common sense)
  • Practical Knowledge of USP, PhEur and Biosafety/Biosecurity requirements.
  • Must have a working knowledge of computer software for report generation (Word, Excel and Access)

Working Conditions:

This position takes place in an office and laboratory environment.  This includes wearing protective equipment as needed, particularly for Bio-containment level-2.

Conclusions:

The Job Description outlines the Key Accountabilities of the position and should not be considered a detailed description of all requirements that may be inherent in the job.

If you are interested in this position, please Apply Online .

Be sure to include the reference number of the position and attach your resume.

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