Quality Assurance Associate- Batch Release

Résumé du poste

Responsible for the final disposition of incoming materials and radiopharmaceutical drug product batches to ensure they meet specifications and cGMP requirements. This includes reviewing batch records, managing deviations, and acting as a liaison for client-related batch issues.

Détails du poste

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

Ce que vous ferez

Responsible for the final disposition of incoming materials and radiopharmaceutical drug product batches to ensure they meet specifications and cGMP requirements. This includes reviewing batch records, managing deviations, and acting as a liaison for client-related batch issues.

Exigences

Requires a B.Sc or M.Sc in life sciences with 2-5 years of experience in a GMP regulated environment. Candidates must have in-depth knowledge of Health Canada, FDA, EU GMP, ICH, and ISO regulations pertaining to sterile products.

Avantages

• Group Health & Dental Benefits • Rrsp Matching Program • Perkopolis • Employee Assistance and Wellness Programs • Parking Allowance

Compétences indiquées

• Assurance qualité · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Batch Release
• cGMP Compliance
• Quality Assurance
• Regulatory Compliance
• Batch Record Review
• CAPA
• ERP Systems
• Sterile Pharmaceuticals
• Annual Product Quality Reviews
• Internal and External Auditing
• Change Control
• Media Fill Review

Domaines d’emploi

• Healthcare
• Manufacturing
• Science & Research
• Engineering