Quality Assurance Associate

3 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 **will help to ensure GMP compliance during production of radiopharmaceuticals. This position will act as an interface between quality, radiopharmaceutical development, regulatory and production to ensure that all regulated activities listed below are conducted in compliance with relevant regulations and internal procedures.
- **Location: Hamilton (On-site)**

**What You Will Do**
- QA activities associated with supply of AtomVie products; these include review of non-conformance reporting and investigations, follow up with CAPAs and change control.
- Participate in Batch Record Review to release marketed and clinical products for use, as well as retrospective Batch Record Close-out.
- Review standard operating procedures (SOPs), Master Batch Records, Standard Test Methods and other controlled documents for compliance with regulations and propose changes for review and approval.
- Review and approval of specifications for incoming raw materials and for finished products.
- Review stability protocols for compliance.
- Review reports for compliance with protocols, quality system and regulatory requirements.
- Support maintenance and improvement of the Quality Systems.
- Represent Quality Assurance on project teams.
- Provide support to internal and external audits by the AtomVie and participate in regulatory inspections of AtomVie facilities, as needed.
- Assist in drafting and finalizing Annual Product Quality Reviews.
- Develop and maintain an in-depth knowledge of key regulations and guidance documents, pertinent to Quality Assurance and use this knowledge to improve the quality system; participate in building the AtomVie Quality System according to Health Canada, EU and FDA regulations, ICH Q10 and ISO guidance.
- Other duties as assigned

**Skills & Experience Required**
- A B.Sc or M.Sc in the life sciences with 1-5 years of experience in a GMP or equivalent regulated environment
- Training and experience in quality systems, quality audits, documentation, change control, CAPAs and review of quality records
- Strong understanding of Health Canada, FDA and EU GMP regulations, with specific knowledge of the regulations as they pertain to sterile products
- Proficiency in the English language both written and oral and excellent communication skills; detail-oriented
- Ability to work independently with mínimal supervision
- Flexibility in work schedule to support a 24/7 production environment

**AtomVie Offers**:

- Group Health & Dental Benefits
- RRSP Matching
- Wellness Benefit
- Parking Reimbursement
- Training & Career Development
- Opportunity for long-term growth
- Join a passionate team making a difference in patients’ lives

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