Quality Control Supervisor

3 months 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**

**What You Will Do**
- Provide leadership by setting clear expectations, providing guidance, and fostering a positive team environment.
- Oversee quality control testing of incoming materials, drug substances, finished drug products according to standard methods, ensuring aherence to GMP standards.
- Manage client projects, communications, presentations, meetings while providing technical support.
- Provide analytical support for new analytical techniques, new projects, and method development.
- Coordinate and schedule daily activities of analysts/technicians to ensure that the team is able to plan, implement and complete assigned tasks in a timely fashion ensuring consistent high quality as per the GMP and company SOPs.
- Conduct investigations for testing failures and non-conformances, implementing corrective actions and assessing CAPA effectiveness.
- Provide training, coaching and enforcing policies while monitoring performance and conducting reviews to support career development.
- Maintain documentation for regulatory compliance inlcuding nuclear safety requirements.
- Verify laboratory records and ensure GMP regulations.
- Author, revise, create and review technical documents, including INVs, NCs, CAPAs, validation documents (protocols, reports), STMs, and other technical documents with input from SMEs.
- Ensure that routine quality operations including equipment maintenance and facility housekeeping are properly maintained.
- Assist team members in toubleshooting equipment systems (HPLCs, GCs, LSC, Gamma Counter, Gamma Spec, etc.).
- Maintain and expand the team’s job knowledge in analytical quality topics, industry regulations, participating in educational opportunities, and reading professional publications.
- Monitor adherence to radiation safety compliance, identify and implement process improvements, and provide training to staff.
- Complete all other duties, as required.

**What You Bring to the Role**
- Ability to lead, coach and motivate a team.
- Ability to cultivate strong working relationships with internal and external stakeholders, fostering collaboration and mutual respect.
- Excellent communication skills (written and verbal)
- Demonstrated ability to successfully prioritize, manage time well, multitask and troubleshoot
- Knowledgeable in use of HPLC, GC, and other analytical techniques
- Knowledge of chromatographic Data Software for relevant equipment, use of spreadsheets (Excel), databases, and word processing software.

**Requirements**:

- M.Sc. or Ph.D in Chemistry, Biological Chemistry, Biotechnology, or a related disciplinee.
- 5 - 10 years of previous hands-on laboratory experience in pharma/biotech QC testing laboratories, performing routine testing, method transfer, method development, and validation.
- 3 years of demonstrated leadership experience.
- Experience in analytical techniques for chemical testing (e.g. HPLC, GC, TLC, ICP, wet chemistry, etc.) and biological testing (ELISA, IRF, SDS-PAGE, Bacterial Endotoxins, cell culture, etc.), as well as material characterization (Gamma Spectroscopy, NMR, MS, IR, MALDI, etc.)
- Flexibility to support a 24/7 production environment.
- Ability to lift 23 kilograms required

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

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