Quality Control, Microbiology Supervisor
- Charlottetown, PE
- $90,822-141,910 per year
- Permanent
- Full-time
- Providing guidance and oversight to direct or indirect reports including QC microbiology and environmental monitoring staff. Responsible for human resources services for direct or indirect reports; including pay, attendance management, and employee performance management.
- Administering the environmental monitoring program throughout the facility encompassing the compliance of the program, the functionality of the equipment and conduct of the personnel.
- Ensuring that the training of all members of the microbiology and environmental monitoring programs are up to date and the procedures they follow are compliant.
- Taking a lead role in designing, outlining and executing investigation plans and the execution of any associated work to determine root causes including identifying contaminants and environmental isolates associated with quality events (non-conformances, CAPAs, etc.)
- Designing and reviewing the validation and verification of microbiology methods and periodically reviewing departmental and interdepartmental SOPs to ensure compliance with current guidelines including but not limited to USP, ICH, FDA, Health Canada, ISPE and Ph. Eur.
- Acting as the Biosafety officer for the BSL2 microbiology and lab in the facility and ensure compliance with PHAC guidelines if required.
- Providing information and presentations on the environmental monitoring program and microbiological lab activities to internal stakeholders and our clients.
- Reviewing of QC records and data for completeness, correctness and compliance with GMP.
- Providing training and support for instrumental and bench techniques for the microbiology lab.
- Maintaining accurate, real-time records of all laboratory activities and ensuring all team members are maintaining accurate, up-to-date, compliant records.
- Bachelor of Science degree in Microbiology or related discipline.
- Master of Science or PhD is considered an asset.
- 5 + years of relevant work experience in a GMP or GLP environment.
- 7+ years of Microbiology experience or relation experience in a life sciences field; or equivalent combination of education and experience.
- Previous supervision and mentorship of junior staff members is required.
- Proficiency in microbiological techniques employed in a regulatory environment:
- Sterility per USP
- Bioburden per USP
- Microbial identification
- Subculturing
- Media Preparation
- Methodology for handling/testing materials inside a BSC
- Experience leading environmental monitoring investigations in sterile manufacturing environments is considered an asset.
- Tracking/trending environmental monitoring data.
- Ability to lead a project within QC, including collaborating with internal and external clients, auditors and presenting data and results clearly and concisely.
- Knowledge of cGMP regulations/guidelines (Health Canada, FDA, EU Annex as well as international regulations (i.e. International Committee on Harmonization (ICH Q &, USP, EP, ISO Standards) pertaining to the microbiology, environmental monitoring, and cleaning validation programs to support production of drug products.
- Robust technical writing skills, with experience in writing and reviewing SOP's and reports.
- Proficient communicator, both written and oral.
- Knowledge of current Good Manufacturing Practices (cGMP).
- Ability to work independently with minimal supervision or informally leading people, projects and/or programs.