Sterility Assurance Associate
4 weeks ago
The Sterility Assurance Associate facilitates the training and auditing program for APA personnel and support personnel to support the Sterility Assurance Program at Pillar5 Pharma. The Sterility Assurance Specialist reports to the Sterility Assurance Manager.
RESPONSIBILITIES:
Co-ordinate and execute aseptic initial and final gown qualification for APA personnel and support personnel. Providing practice classroom session in gowning techniques, proper environmental monitoring practices for air and surface sampling, sampling requirements and good documentation practices.
Co-ordinate and execute ongoing aseptic gown requalification and retraining for APA personnel and support personnel.
Schedules and performs weekly and follow-up audits for all gown certified personnel, evaluating aseptic practices to meet recommended gown contamination rates %. Provides personnel with written reports, in person reviews of their audit report, and follow-up audits.
Provide training videos that adhere to standard work instructions to support the aseptic practices and behaviour program.
Support the Media Fill Program, as a qualified media fill inspector.
Execute the completion of assigned CAPA and EC for sterility assurance related events.
Support the garment management program to ensure cleanroom garments and associated barrier systems are in good standing to maintain contamination control. Responsible for issuing SQC for cleanroom garment concerns.
Provides contamination control support and troubleshooting to the APA.
Assist the Sterility Assurance Manager in the completion of audits for the Sterility Assurance Audit Program (ML 099).
Co-ordinate changes to the Micro data portal and the Gown Qualification Tracker.
Provides microbiology laboratory support for disinfectant efficacy studies.
Responsible for supporting investigations and preparation of reports for events in the APA that result in Environmental monitoring report (EMR) and Environmental Risk Assessments (ERA). EMR and ERAs are approved by the Sterility Assurance Manager.
Write and modify SOPs for the gowning program and the gown management program.
Performs other tasks as identified by the Sterility Assurance Manager.
**REQUIREMENTS**:
Bachelor's degree in microbiology, biochemistry, or biology. University courses in microbiology are required for this position.
2-3 years experience in Microbiology in a pharmaceutical manufacturing environment.
Experience working in a cGMP pharmaceutical manufacturing environment.
Ability to think objectively, have excellent communication and interpersonal skills.
**Job Type**: Temporary
Contract length: 12 months
**Salary**: $39,404.55-$94,512.56 per year
Schedule:
Monday to Friday
Ability to commute/relocate:
Arnprior, ON: reliably commute or plan to relocate before starting work (required)
Work Location: In person
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