Director, Quality Assurance
Hamilton, ONAtomVie Global Radiopharma Inc.
15+ ans5+ gestionCandidates need a science degree (BSc, MSc or PhD), about 15 years of pharmaceutical or biotech QA experience with at least 5 years managing direct reports, and deep knowledge of Health Canada, FDA and EU GMP rules for sterile products.
electronic quality management system
VP Quality
Hamilton, ONAtomVie Global Radiopharma Inc.
15+ ans10+ gestionCandidates need a relevant science degree (BSc, MSc or PhD), at least 15 years of pharmaceutical QA experience in an FDA, Health Canada or EMA regulated industry, and 10 years managing cross-functional QA and QC teams. Sterile manufacturing, facility design and validation, and leading regulatory inspections are must-haves.
Good manufacturing practices, Radiopharmaceuticals, Regulatory compliance, Strategic planning, Quality assurance, Quality control
AD Technologist
Hamilton, ONAtomVie Global Radiopharma Inc.
AtomVie Global Radiopharma needs candidates with a college diploma in chemistry, biotechnology, biology or a related field, or two years of university. Previous lab experience, pharmaceutical cGMP or aseptic work, and Canadian Nuclear Safety Commission experience are assets. Candidates must lift up to 10 kg, wear PPE, and be proficient in spreadsheets and word processing.
pH meter, analytical balance, dose calibrator, water bath, sonicator, biological safety cabinet
Microbiology - Technical Writer & Data Reviewer
Hamilton, ONAtomVie Global Radiopharma Inc.
2+ ansCandidates need a science degree, 2 to 3 years of GMP-regulated experience, and experience reviewing lab documents and writing technical reports. Strong writing, attention to detail, and comfort with CAPAs and quality systems are essential.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Electronic quality management system
Quality Assurance Associate- Batch Release
Hamilton, ONAtomVie Global Radiopharma Inc.
3+ ansCandidates need a B.Sc or M.Sc in the life sciences and 3-5 years of experience in a GMP or similarly regulated environment, preferred. They must know Health Canada, FDA, EU GMP, ICH and ISO rules for sterile products, communicate well in English, and work flexible shifts.
ERP system
QA - Data Reviewer, Associate
Hamilton, ONAtomVie Global Radiopharma Inc.
5+ ansCandidates need post-secondary education in engineering, chemistry, microbiology or a related field, plus at least 5 years of analytical testing or data review in pharmaceutical or radiopharmaceutical work. GMP experience, strong knowledge of data integrity and 21 CFR Part 11, and excellent English communication are required.
HPLC, GC, TLC, pH meter
CQV Specialist I (Lab)
Hamilton, ONAtomVie Global Radiopharma Inc.
2+ ansCandidates need a college diploma in a technical field or relevant experience, typically 2 to 5 years in a GMP pharmaceutical lab, ideally in metrology. They need knowledge of Health Canada and FDA regulations, experience with Empower CDS and Waters HPLC systems, and strong technical writing skills. The role also requires being able to lift 50 lbs and work in confined spaces.
Empower CDS, Waters HPLC, Gas chromatography, CMMS