Quality Assurance Data Reviewer Associate

7 days ago

Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time
About the Role

The Data Reviewer Associate is a critical position in ensuring the integrity of data generated in our laboratories. This role is responsible for verifying records related to radiopharmaceuticals, ensuring compliance with Good Manufacturing Practices (GMP) and data integrity principles.

Key Responsibilities
  • Review data from various equipment, including HPLC, GC, and pH meters, to ensure accuracy and completeness.
  • Verify that test methods, protocols, and Standard Operating Procedures (SOPs) were followed by chemists, scientists, and biochemists.
  • Conduct periodic reviews of audit trails in equipment as prescribed by internal SOPs.
  • Contribute to laboratory investigations of Out of Specification and/or Out of Trend results.
  • Collaborate with stakeholders to ensure data meets ALCOA+ integrity standards.
  • Provide guidance and support to laboratory staff and management to maintain data to AtomVie standards and regulatory requirements.
  • Ensure compliance with Health and Safety policies, procedures, and regulations applicable to their work.
Requirements
  • Post-Secondary Education in Engineering, Chemistry, Microbiology, or a related field.
  • Minimum 5 years of experience conducting testing or reviewing analytical chemistry data in the pharmaceutical, radiopharmaceutical, or biotechnology field.
  • Experience working in a GMP environment is required.
  • Proficiency in the English language, both written and oral, and excellent communication skills.
What We Offer
  • Group Health & Dental Benefits.
  • RRSP Matching Program.
  • Perkopolis.
  • Employee Assistance and Wellness Programs.
  • Parking Allowance.

AtomVie 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. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process.

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