Microbiologist - Sterility and Quality Assurance Specialist

1 week ago


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

About AtomVie Global Radiopharma Inc.

We are a leading global manufacturer and distributor of clinical and commercial radiopharmaceuticals, dedicated to advancing high-quality drugs for the treatment and diagnosis of diseases. Our mission is to transform lives by revolutionizing healthcare.

Role Overview

The Microbiologist - Sterility and Quality Assurance Specialist 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.

Main Responsibilities

Conduct routine microbiological testing, including sterility testing, growth promotion, bioburden testing, microbial identification, and other tests according to USP and EP.Perform 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.Manage inventory and 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 writing technical documents, customer reports, and internal reports.Support the Media Fill program.Understand and work under Health Canada GMP requirements for sterile pharmaceuticals and Annex to Good Manufacturing Practices (GMP) guidelines for Positron Emitting Radiopharmaceuticals (PERs).Plan, implement, and complete assigned tasks in a timely fashion, ensuring consistent high quality.Investigate testing failure and non-conformances, implementing 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 Health Canada and FDA GMP requirements for sterile pharmaceuticals.Comply with Canadian Nuclear Safety Commission regulations.Ensure compliance with Health and Safety policies, procedures, and regulations applicable to their work.Complete other duties as required.

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