Quality Assurance Specialist, Data Reviewer

7 days ago

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

The Quality Assurance Specialist, Data Reviewer plays a critical role in ensuring the integrity of data generated in our Analytical Development and Quality Control laboratories.

This position is responsible for verifying the accuracy and completeness of records related to radiopharmaceuticals, ensuring compliance with Good Documentation Practices (GDP) and 21 CFR Part 11 regulations.

Key Responsibilities
  • Review and verify data generated from various equipment, including HPLC, GC, and pH meters.
  • Ensure that test methods, protocols, and Standard Operating Procedures (SOPs) are followed by laboratory staff.
  • Conduct periodic reviews of audit trails and investigate 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 on data integrity and compliance with regulatory requirements.
  • Ensure compliance with Health and Safety policies, procedures, and regulations.
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.

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