| Reference Number: 89 |
| Location |
Pointe-Claire, Quebec |
| Reports To: |
Director of Quality Assurance/Quality Control |
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| Description |
Overall Job Summary:
The Microbiology Laboratory Supervisor is responsible for proper operation of microbiology laboratory.
Specific Accountabilities:
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Responsible for the smooth operation of the microbiology lab. This includes making decisions regarding timelines, personnel, sampling, testing, etc.
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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.
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Responsible for reviewing and approving certificate/reports of analysis for raw materials, packaging materials and waters.
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Responsible for maintaining adequate supplies of lab materials needed.
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Responsible for communicating important information to other departments/sites and liaising with Third-Party Laboratories
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Responsible for performing trending of Environmental Monitoring results and related issues and reporting these to upper Management.
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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.
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Responsible for conducting OOS investigations and issue Non-Conformance-Report as required
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Responsible for conducting environmental-deviation-report investigations.
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Responsible for troubleshooting of the equipment.
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Responsible for reviewing and authoring documents such as SOP, WI, QCTM,etc., and ensuring they are in compliance with current regulations.
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Responsible for validating/transferring testing methods and instruments (including development of Validation Protocols and reports and possibly execution of them).
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Responsible for ensuring that that all testing is performed and recorded according to Bioniche and GLPs/GMPs requirements.
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Responsible for reporting any major product quality problem and any safety/security issue to Manager promptly as they arise.
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Responsible for acting as the Biosafety Officer for the Plant and performed all related tasks and responsibilities.
Education, Work Experience & Competencies
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Minimum B.S. in Microbiology, Biology, or Biochemistry or relevant science discipline
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5 years of experience in QC laboratory in pharmaceutical or bio/pharmaceutical environment
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2 years of experience in a supervisory role
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Must be Bilingual (English/French)
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Deep knowledge of GMPs as they relate to laboratory work
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Organizational/planning skills
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Interpersonal and leadership skills and team spirit
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Initiative and good judgment (common sense)
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Practical Knowledge of USP, PhEur and Biosafety/Biosecurity requirements.
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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.
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Be sure to include the reference number of the position and attach your resume.
