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Data Integrity Specialist

2 months ago

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

About the Role

The Data Integrity Specialist is responsible for ensuring compliance and data integrity through verification of records generated in sampling, preparation, instrumental analysis, data evaluation and calculation of reportable results related to radiopharmaceuticals at AtomVie Global Radiopharma Inc. This role is critical in sustaining data integrity principles in Analytical Development and Quality Control laboratories operating at AtomVie.

Key Responsibilities

  • Reviews data carried out using a wide variety of equipment including but not limited to HPLC, GC (including headspace), pH meters
  • Reviews the completeness of the records generated in sampling, preparation, instrumental analysis, data evaluation and calculation of reportable results to verify integrity of all data generated and reported
  • Ensures the test methods, protocols and Standard Operating Procedures (SOPs) were followed by chemists, scientists and biochemists
  • Conducts and documents periodic review of audit trails in the variety of equipment as prescribed by internal SOPs
  • Contributes to laboratory investigations of Out of Specification and/or Out of Trend results
  • Works collaboratively with stakeholders to ensure the data meets ALCOA+ integrity
  • Provides guidance and support to laboratory staff and management, ensuring the data is maintained to AtomVie standards and regulatory requirements, mentoring and coaching these staff members to understand the importance and implications of data integrity in the laboratory
  • Ensures compliance with Health and Safety for all 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; detail oriented

What We Offer

  • Group Health & Dental Benefits
  • RRSP Matching Program
  • Perkopolis
  • Employee Assistance and Wellness Programs
  • Parking Allowance

AtomVie Global Radiopharma Inc. 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. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.