Quality Assurance Associate

at  AtomVie Global Radiopharma Inc

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.

REQUIREMENTS

• A B.Sc or M.Sc in the life sciences with 1-5 years of experience in a GMP or equivalent regulated environment is preferred.
• Knowledge of maintaining a cGMP pharmaceutical manufacturing operation according to FDA, Health Canada and EMA requirements for investigational and commercial products.

ABOUT THE ROLE

Reporting to the Quality Assurance Manager, the Quality Assurance Associate – Batch Release will ensure GMP compliance during routine 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.
To support the operational needs of a 24/7 production environment, the work schedule for this position will include shifts scheduled from Sunday through to Saturday as assigned by the Quality Assurance Manager based on a 37.5 hour work week and in accordance with the Company’s Policies & Procedures.

WHAT YOU WILL DO

• Review and release of executed batch records for confirmation through commercial drug products, support maintenance and improvement of the Quality Systems.
• Review and release of materials and components as per their specification for use in production in a timely manner.
• 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.
• Support investigations for testing failure (OOS) and non-conformances and implement corrective actions (CAPA) where required.
• Responsible for QA activities associated with supply of AtomVie products.
• Plan, implement, and successfully complete assigned tasks in a timely fashion ensuring consistent high quality.
• Represent Quality Assurance on project teams, where required.
• Adhere to GMP regulations by maintaining complete records.
• Develop and maintain an in-depth knowledge of key regulations and guidance documents, pertinent to Product Development and Quality and use this knowledge to improve the quality system; participate in building the AtomVie Quality System according to Health Canada and FDA regulations, ICH Q10 and ISO guidance.
• Understand and work under the Health Canada, FDA, and EMA GMP requirements for sterile pharmaceuticals.
• Understand and work under the Canadian Nuclear Safety Commission regulations.

WHAT YOU BRING TO THE ROLE

• Demonstrated ability to successfully prioritize, manage time well, and multitask.
• Ability to work independently and possess excellent organizational skills.
• Strong understanding of Health Canada, FDA and EU GMP regulations, with specific knowledge of the regulations as they pertain to sterile products.
• Ability to cultivate strong working relationships with internal stakeholders, fostering collaboration and mutual respect.
• Proficiency in the English language both written and oral and excellent communication skills; detail oriented.
• Flexibility in schedule to support a 24/7 operational environment.