Overview
Quality Assurance Associate- Batch Release Jobs in Hamilton, Canada at AtomVie Global Radiopharma Inc.
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.
Location
Atom Vie Global Radiopharma Inc, Hamilton ON (Onsite).
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 Atom Vie and participate in regulatory inspections of Atom Vie 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 3-5 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.
Compensation
Annual salary starts at $65,000. Compensation is based on relevant industry experience, academic credentials, and qualifications.
Atom Vie Offers
Group Health & Dental Benefits (from day
1)
RRSP Matching Program
Perkopolis
Employee Assistance and Wellness Programs
Parking Allowance
Atom Vie does not use artificial intelligence or automated decision-making tools in any part of the recruitment, screening, or selection process.
We are 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. 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.
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Title: Quality Assurance Associate- Batch Release
Company: AtomVie Global Radiopharma Inc.
Location: Hamilton, Canada
Category:
