Sterile Product Microbiologist
4 days ago
About Us
">- At AtomVie Global Radiopharma Inc., we are a leading GMP manufacturer and distributor of clinical and commercial radiopharmaceuticals.
Our Vision
">We strive to transform patients' lives by advancing high-quality drugs for the treatment and diagnosis of diseases.
">The Role
">The Sterile Product Microbiologist will be responsible for completing day-to-day tasks assigned, including routine microbiological testing such as sterility testing, growth promotion, bioburden testing, microbial identification, and other tests according to USP and EP.
">Key Responsibilities
">- 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 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/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 Micro related failures and non-conformances.
- Assist in the writing of technical documents, customer and internal reports, SOPs, protocols.
- Support the Media Fill program.
- Understand and work under the Health Canada GMP requirements for sterile pharmaceuticals and the Annex to the Good Manufacturing Practices Guidelines Good Manufacturing Practices (GMP) 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 policies, procedures and regulations applicable to their work.
- Complete all other duties as required.
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.
Estimated Salary
">$65,000 - $90,000 per year based on location and experience.
">Benefits
">- Group Health & Dental Benefits.
- RRSP Matching Program.
- Perkopolis.
- Employee Assistance and Wellness Programs.
- Parking Allowance.
Diversity, Equity, and Inclusion
">AtomVie Global Radiopharma Inc. is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients.
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