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 Shop Floor Quality Associate works collaboratively with operational stakeholders to ensure quality oversight, leadership and direction to other departments’ SMEs through real time decision making in order to ensure AtomVie remains in compliance to its systems, external client expectations and Good Manufacturing Practices (GMPs).

What You Will Do

• Effectively drive the management and oversight of quality issues (in real time where possible)
• Collaborate with Production and Microbiology (where necessary) to provide real-time oversight of Production activities by advising Operators on best practices and reinforcing GMP
• Make decisions using problem-solving skills (in real time where possible) and support SMEs with identifying effective corrective/preventive actions
• Act as QA’s representative for the release of GMP areas
• Provide documentation support and perform routine QA review of records (i.e., pest control, housekeeping, logbooks, binders, etc.)
• Support and participate in audits by regulatory authorities and AtomVie clients as needed
• Serves as the Quality Assurance representative on cross-functional teams to drive quality focused decision making
• Communicate quality and compliance issues to all relevant stakeholders in a timely manner
• Ensure AtomVie is inspection ready and is operating within a compliant quality environment
• Ensure compliance with Health and Safety for all policies, procedures and regulations applicable to their work.
• Support all other duties as assigned

What You Bring to the Role

• Adaptability with a desire for working in a fast-paced, growth-oriented environment
• Ability to work with a sense of urgency, prioritize work, meet objective/deadlines with strong organizational skills
• Strong project management skills with the ability to work independently and within a team
• Ability to drive improvement projects and deliver high-quality work even under pressure
• Ability to handle multiple tasks and competing priorities concurrently and in a timely fashion
• Ability to solve problem with evidence of good judgment and decision-making skill
• Strong client-facing and teamwork skills

Requirements

• BSc or equivalent in Pharmacy, Engineering, Chemistry, Microbiology or a related field
• 1-2 years of relevant experience in the pharmaceutical, radiopharmaceutical or biopharmaceutical industry is required, with up to 5 years preferred
• Strong understanding of Health Canada and FDA GMP regulations, with specific knowledge of regulations as they pertain to sterile products
• Flexibility in work schedule to support a 24/7 production environment

AtomVie Offers

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

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.We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.