QA - Data Reviewer, Associate

at  AtomVie Global Radiopharma Inc

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.

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.

ABOUT THE ROLE

The QA – Data Reviewer, Associate is responsible for ensuring GMP 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. This role is critical in sustaining data integrity principles in Analytical Development and Quality Control laboratories operating at AtomVie.

WHAT YOU WILL DO

• 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
• Ensure 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
• Provide 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 GDP and data integrity in the laboratory has at AtomVie.
• Ensure compliance with Health and Safety for all policies, procedures and regulations applicable to their work.

WHAT YOU BRING TO THE ROLE

• Working knowledge and thorough understanding of data integrity, Good Documentation Principles (GDP) and concept of 21 CFR Part 11 (and associated regulations)
• Working knowledge of laboratory equipment systems to perform audit trail of testing
• Familiarity with scientific principles pertaining to analytical records review
• Understanding or principles and requirements for analytical methods qualification, validation and verification
• Aptitude for analytical data analysis and interpretation
• Flexibility in schedule to support a 24/7 operational environment