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Data Integrity Specialist

2 months ago

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

At AtomVie Global Radiopharma Inc., we are seeking a highly skilled QA - Data Reviewer to join our team. As a key member of our Analytical Development and Quality Control laboratories, you will play a critical role in ensuring the integrity of our data and maintaining compliance with Good Documentation Principles (GDP) and 21 CFR Part 11 regulations.

Key Responsibilities
  • Verify the accuracy and completeness of analytical records generated in sampling, preparation, instrumental analysis, data evaluation, and calculation of reportable results.
  • Ensure that test methods, protocols, and Standard Operating Procedures (SOPs) are followed by chemists, scientists, and biochemists.
  • Conduct periodic reviews of audit trails in various equipment as prescribed by internal SOPs.
  • 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.
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.