QA - Data Reviewer, Associate

2 days ago

Hamilton, Canada AtomVie Global Radiopharma Inc. Full time

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.

**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

**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.

**AtomVie Offers**
- Group Health & Dental Benefits (from day 1)
- RRSP Matching Program
- Perkopolis
- Employee Assistance and Wellness Programs
- Parking Allowance

  • Associate I, Quality Assurance

    7 days ago

    Hamilton, Canada OmniaBio Full time

    Position Summary: - As Associate I, Quality Assurance (QA), at OmniaBio, you are a motivated individual in the field of Good Manufacturing Practices (GMP) manufacturing of cell and gene therapy products who is driven by the opportunity to enable clinical translation of cell therapy and regenerative medicine. The QA team is responsible for all aspects of GMP...

  • Associate Ii, Quality Control

    2 days ago

    Hamilton, Canada OmniaBio Full time

    **Position Summary**: As the Associate II, Quality Control, at OmniaBio, you are an experienced individual in the field of quality control (QC) for Good Manufacturing Practices (GMP) manufacturing of cell and gene therapy products, driven by the opportunity to enable clinical translation of cell therapy and regenerative medicine. The Associate II, Quality...

  • Quality Assurance Associate I

    3 weeks ago

    Hamilton, Canada OmniaBio Full time

    Position Summary As Associate I, Quality Assurance (QA), at OmniaBio, you are a motivated individual in the field of Good Manufacturing Practices (GMP) manufacturing of cell and gene therapy products who is driven by the opportunity to enable clinical translation of cell therapy and regenerative medicine. The QA team is responsible for all aspects of GMP for...

  • GMP QA Associate I – Cell Therapy Manufacturing

    3 weeks ago

    Hamilton, Canada OmniaBio Full time

    A leading biotechnology company in Ontario seeks an Associate I, Quality Assurance (QA) to support GMP activities in cell therapy production. This role involves delivering quality assurance services, preparing documentation, and ensuring compliance with regulatory standards. Ideal candidates possess a high school diploma plus relevant college courses, with...

  • Quality Assurance Associate

    2 weeks ago

    Hamilton, Canada Centre For Probe Development And Commercialization Full time

    AtomVie is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases. **About the Role** - Reporting to the Supervisor, Quality Assurance Operations, the - **Quality Assurance...

  • Quality Assurance Associate

    3 days ago

    Hamilton, Canada AtomVie Global Radiopharma Inc. Full time

    AtomVie is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases.**About the Role** - Reporting to the Supervisor, Quality Assurance Operations, the - **Quality Assurance...

  • Quality Assurance Associate

    2 weeks ago

    Hamilton, Canada AtomVie Global Radiopharma Inc. Full time

    AtomVie is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases. **About the Role** Reporting to the Supervisor, Quality Assurance Operations, **the Quality Assurance Associate...

  • Quality Assurance Associate

    2 weeks ago

    Hamilton, Canada Centre For Probe Development And Commercialization Full time

    AtomVie is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases. **About the Role** - Reporting to the Supervisor, Quality Assurance Operations, the **Quality Assurance Associate...

  • Quality Assurance Associate- Batch Release

    1 week ago

    Hamilton, Canada AtomVie Global Radiopharma Full time

    **AtomVie 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...

  • OmniaBio: Quality Assurance Associate II

    7 days ago

    Hamilton, Canada OmniaBio Inc Full time

    OmniaBio: Quality Assurance Associate II (Compliance) (18-month contract) Hamilton, ON, Canada Job Description Posted Tuesday, January 6, 2026 at 5:00 AM | Expires Wednesday, January 21, 2026 at 4:59 AM About OmniaBio: OmniaBio Inc. is a technology-driven, global CDMO specializing in cell and gene therapies, with a mission to transform biomanufacturing...