Senior Microbiologist and Quality Assurance Specialist

7 days ago

Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time

About the Role

We are seeking an experienced Senior Microbiologist and Quality Assurance Specialist to join our team at AtomVie Global Radiopharma Inc.

The ideal candidate will have a strong background in microbiological testing, including sterility testing, growth promotion, bioburden testing, microbial identification, and other tests according to USP and EP.

This is a unique opportunity to work with a leading manufacturer and distributor of clinical and commercial radiopharmaceuticals, where you will be responsible for maintaining the highest quality standards and ensuring compliance with Health Canada GMPs and FDA regulations.

Key Responsibilities:

  • Conduct routine microbiological testing, including sterility testing, growth promotion, bioburden testing, microbial identification, and other tests according to USP and EP
  • Conduct peer review of laboratory records
  • Conduct routine environmental monitoring according to SOPs
  • Maintain 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 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

Requirements:

  • B.Sc. in Microbiology or a related field
  • 1-3 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

About Us:

At AtomVie Global Radiopharma Inc., we value 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. We are committed to fostering a workplace that values these principles.

Salary and Benefits:

The salary range for this role is approximately $85,000-$110,000 per year, depending on experience. Additionally, we offer a comprehensive benefits package, including group health and dental benefits, RRSP matching program, Perkopolis, employee assistance and wellness programs, and parking allowance.

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