Quality Assurance Associate- Batch Release

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributor 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 QA Associate for Batch Release is responsible for final disposition of incoming materials and final radiopharmaceutical drug product batches. This role ensures that all batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements.

What You Will Do

Determine final disposition of batches by reviewing all required documentation, including but not limited to batch records and change controls, and determining the status of deviations

Complete media fill reviews, reporting any issues

Participate in the creation and revision of standard operating procedures, and specifications

Review Certificates of Analysis, material management or other similar documentation for internal and external customers

Release incoming materials (e.g. activity, raw materials, components etc.) using the ERP system

Act as liaison with clients for batch related issues.

Assist in drafting and finalizing Annual Product Quality Reviews

Provide support for the launch of new products

Provide support for to Management by gathering and analyzing data

Recommend, support and drive cross-functional and interdepartmental continuous improvement efforts

Provide support to internal and external audits by AtomVie and participate in regulatory inspections of AtomVie facilities, as needed

Plan, implement, and successfully complete assigned tasks in a timely fashion ensuring consistent high quality.

Support and implement corrective actions (CAPA) where required

Adhere to GMP regulations by maintaining complete records and ensuring compliance with Health Canada, FDA, and EMA requirements for sterile pharmaceuticals.

Ensure compliance with Health and Safety for all policies, procedures and regulations applicable to their work.

Complete other duties as assigned

What You Bring To The Role

Proficiency in the English language both written and oral and excellent communication skills; detail-oriented

Ability to work independently and possess excellent organizational skills.

A collaborative mindset, with the ability to work cross-functionally with various teams.

High attention to detail and the ability to maintain accuracy in reviewing batch records, documentation, and regulatory compliance.

Requirements

A B.Sc or M.Sc in the life sciences with 2-5 years of experience in a GMP or equivalent regulated environment is preferred.

In-depth knowledge of key regulations and guidance documents, pertinent to Product Development and Quality including Health Canada, FDA, EU GMP, ICH and ISO, with specific knowledge of the regulations as they pertain to sterile products

Flexibility 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

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.