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Quality Auditor

1 month ago

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

The QC Analyst I will be responsible for working in accordance with company policies and within GMPs while contributing technical expertise to support current products and develop future drugs within the AtomVie portfolio. They will also be responsible for quality control testing of materials and finished drug products, specifically radiopharmaceuticals. The ideal candidate will be proficient in executing chemical tests using advanced analytical techniques, including HPLC, GC, TLC, bacterial endotoxin testing, and pH measurements, while adhering to standard operating procedures (SOPs) and Good Manufacturing Practices (GMP).

This position involves set evening, night, or early morning shifts, with weekend availability required (e.Quality control testing of materials and finished drug products (radiopharmaceuticals) including chemical tests using various analytical techniques such as HPLC, GC, TLC, bacterial endotoxin testing, pH, etc. Responsible for the facility maintenance and housekeeping, maintain inventory of reagents and supplies, waste disposal, etc.
Conducting investigations for testing failure and non-conformances
Author, revise, and review technical documents, including SOPs, validation documents, standard test methods according to good documentation practices and reports.
Adhere to Canadian Nuclear Safety Commission and GMP regulations.

Experience routinely executing chemistry techniques such as HPLC, GC and TLC is preferred for this role.
Experience with other lab equipment such as ICP, Gamma Spectroscopy, or Liquid Scintillation Counter is an asset.
Experience working with sterile products is considered an asset

Sc. in Chemistry, Biotechnology or a related field
~Shift flexibility to support 24-hour/7-day manufacturing schedule

Group Health & Dental Benefits (from day 1)
AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process.