11 Aug
|
AtomVie Global Radiopharma
|
Ontario
11 Aug
AtomVie Global Radiopharma
Ontario
About the Role
The Microbiologist will be responsible for completing the day‑to‑day tasks assigned; this embraces routine microbiological testing including sterility testing, growth promotion, bioburden testing, microbial identification, and other tests according to the USP and EP.
What You Will Do
Conduct routine microbiological testing including sterility testing, growth promotion, bioburden testing, microbial identification, and other tests according to the USP and EP.
Conduct peer review of laboratory records.
Conduct routine environmental monitoring of cleanrooms according to SOPs.
Be responsible for the maintenance of the AtomVie Microbiology Laboratory according to Health Canada GMPs, including records, procedures, disposal of waste, materials, equipment, and routine operations.
Support calibration and maintenance of microbiology equipment.
Conduct inventory and management of microbiological materials.
Assist in the closure of change controls, non‑conformances, investigations and CAPAs as specified in the SOPs.
Support investigations for microbiology related failures and non‑conformances.
Assist in writing technical documents, customer and internal reports, SOPs and protocols.
Support the media fill program.
Understand and work under the Health Canada GMP requirements for sterile pharmaceuticals and the annex to the Positive Manufacturing Practices Guidelines for positron emitting radiopharmaceuticals (PERs).
Plan, implement, and successfully complete assigned tasks in a timely fashion, ensuring consistent high quality.
Conduct investigations for testing failure and non‑conformances and implement corrective actions.
Adhere to GMP regulations by maintaining complete records pertaining to all aspects of microbiological testing, routine operations, and equipment maintenance.
Understand and work under the Health Canada and FDA GMP requirements for sterile pharmaceuticals.
Understand and work under the Canadian Nuclear Safety Commission regulations.
Ensure compliance with health and safety for all applicable policies, procedures and regulations.
Complete all other duties as required.
What You Bring to the Role
Proficiency with spreadsheets (e.g. Excel, Google Sheets) and ability to write technical documents and reports.
Good communication skills (in English) and ability to work both independently and cooperatively in a team environment.
Experience in a pharmaceutical cGMP environment; experience in aseptic operations, cleanrooms, and biosafety containment level 2 lab, and working under Canadian Nuclear Safety Commission regulations are assets in this role.
Requirements
B.Sc. in Microbiology or a related field.
1 to 3 years of related experience in microbiological testing such as growth promotion, bioburden, environmental monitoring, sterility and/or bacterial endotoxin.
This position requires shift work and alternating weekends.
Ability to lift and move heavy weights up to 23 kilograms is required.
Compensation
Annual salary starts at $58,000. Compensation is based on relevant industry experience, academic credentials, and qualifications.
AtomVie Benefits
Group health and dental benefits (from day 1).
RRSP matching program.
Employee assistance and wellness programs.
We are committed to fostering a workplace that values diversity, equity, and inclusion. Our aim is to enhance our ability to innovate, collaborate, and better serve our clients and patients. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.
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📌 Microbiologist (Ontario)
🏢 AtomVie Global Radiopharma
📍 Ontario