Quality Assurance Associate- Batch Release

AtomVie Global Radiopharma Inc.; Hamilton; On-site; CAD 60,000 - 75,000; Full time

Job summary

Join a leading global GMP manufacturer in Hamilton as a Quality Assurance Associate. This role focuses on ensuring that radiopharmaceutical batches meet specifications and comply with regulatory requirements. You will review documentation, support audits, and contribute to continuous improvement efforts. Ideal candidates will have a life sciences degree and experience in a regulated environment, with strong communication and organizational skills.

Benefits

Group Health & Dental Benefits

RRSP Matching Program

Employee Assistance and Wellness Programs

Qualifications

• 2-5 years of experience in a GMP or equivalent regulated environment preferred.
• In-depth knowledge of key regulations including Health Canada, FDA, EU GMP.

Responsibilities

• Determine final disposition of batches by reviewing documentation.
• Ensure compliance with GMP regulations and maintain complete records.
• Support internal and external audits and regulatory inspections.

Skills

Communication

Organizational Skills

Attention to Detail

Education

B.Sc or M.Sc in Life Sciences

Job description

Quality Assurance Associate- Batch Release

Quality Assurance Associate- Batch Release

Get AI-powered advice on this job and more exclusive features.

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

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.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at AtomVie Global Radiopharma Inc. by 2x

Sign in to set job alerts for “Quality Assurance Associate” roles.

Quality Assurance Specialist - Transportation

Stoney Creek, Ontario, Canada 1 month ago

Quality Assurance Specialist (HVAC) / Technical Trainer

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.