Microbiologist

at  AtomVie Global Radiopharma Inc

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.
We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.

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.

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 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.

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 and Biosafety Containment Level 2 lab, and working under Canadian Nuclear Safety Commission regulations are assets in this role.