Associate, QA Reviewer
7 days ago
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.
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.
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. Conducts and documents periodic review of audit trails in the variety of equipment as prescribed by internal SOPs
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.
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
Aptitude for analytical data analysis and interpretation
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.
Proficiency in the English language both written and oral, and excellent communication skills; Group Health & Dental Benefits (from day 1)
Employee Assistance and Wellness Programs
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. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process.
-
QA Data Reviewer Associate
7 days ago
Hamilton, ON, Canada AtomVie Global Radiopharma Inc. Full timeAtomVie 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...
-
QA - Data Reviewer, Associate
4 days ago
Hamilton, Canada AtomVie Global Radiopharma Full timeAtomVie 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...
-
QA - Data Reviewer, Associate
2 days ago
Hamilton, Canada AtomVie Global Radiopharma Inc. Full timeAtomVie 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...
-
QA Data Reviewer Associate
2 weeks ago
Hamilton, Canada AtomVie Global Radiopharma Inc. Full timeAtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributor 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...
-
QA Data Reviewer Associate
2 weeks ago
Hamilton, Canada AtomVie Global Radiopharma Inc. Full timeAtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributor 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...
-
QA Data Reviewer Associate
2 weeks ago
Hamilton, Canada AtomVie Global Radiopharma Inc. Full timeAtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributor 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...
-
GMP QA Data Reviewer, Associate — Data Integrity
4 weeks ago
Hamilton, Canada AtomVie Global Radiopharma Inc. Full timeA leading radiopharmaceutical company in Hamilton is seeking a QA – Data Reviewer, Associate to ensure GMP compliance and data integrity. The ideal candidate should have extensive experience in analytical chemistry data review and knowledge of Good Documentation Principles. This role provides an opportunity to mentor staff and uphold high standards within...
-
GMP QA Data Reviewer, Associate — Data Integrity
3 weeks ago
Hamilton, Canada AtomVie Global Radiopharma Inc. Full timeA leading radiopharmaceutical company in Hamilton is seeking a QA – Data Reviewer, Associate to ensure GMP compliance and data integrity. The ideal candidate should have extensive experience in analytical chemistry data review and knowledge of Good Documentation Principles. This role provides an opportunity to mentor staff and uphold high standards within...
-
GMP Data Integrity Reviewer — QA Associate
3 weeks ago
Hamilton, Canada AtomVie Global Radiopharma Inc. Full timeA leading radiopharmaceutical manufacturer in Hamilton is seeking a QA – Data Reviewer. In this full-time role, you will ensure compliance and data integrity in analytical processes. The ideal candidate will have a strong background in data integrity principles, at least 5 years of experience in the pharmaceutical field, and proficiency in both written and...
-
GMP Data Integrity Reviewer — QA Associate
2 weeks ago
Hamilton, Canada AtomVie Global Radiopharma Inc. Full timeA leading radiopharmaceutical manufacturer in Hamilton is seeking a QA – Data Reviewer. In this full-time role, you will ensure compliance and data integrity in analytical processes. The ideal candidate will have a strong background in data integrity principles, at least 5 years of experience in the pharmaceutical field, and proficiency in both written and...
