Quality Assurance (QA) Technician

We are seeking a detail-oriented and reliable Quality Assurance (QA) Technician to support our growing biotech operations. The focus of this role will be to assist with batch record review, material release activities and equipment qualification within a GMP-regulated environment. The QA Technician will report directly to the QA Manager and collaborate closely with other departments to ensure that materials, equipment and products meet the required quality standards.

Key Responsibilities 

• Participate in the review of batch records (MBR) for cell lines, cell bank, and drug product production. Report any discrepancies, deviations, or issues observed during the review.
• Participate in material release activities ensuring compliance with release specifications.
• Participate in equipment qualification, review of documentation
• Assist in reviewing and ensuring compliance with SOPs, deviations, CAPAs, and validation protocols.
• Help in maintaining and ensuring adherence to QA procedures within the organization.
• Assist with internal audits to ensure readiness and compliance with standards.
• Assist in administrative tasks in the eQMS.
• Support the qualification of materials program, including raw materials, consumables, and packaging, under guidance.

Qualification & Experience 

• Bachelor degree in Life Sciences, Biology, Chemistry, Biomedical Sciences, Biotechnology or equivalent
• At least 2 years' experience in quality assurance function within pharmaceutical or biotechnology industry
• Knowledge of GMP and pharmaceutical industry standards, GMP for ATMP is an asset
• Hands-on experience with batch record review and/or equipment qualification  

Skills and Competencies 

• Strong attention to detail and accuracy in documenting processes and reviewing records.
• Communication skills: Ability to effectively collaborate with cross-functional teams to resolve quality issues.
• Technical skills: Proficient in Office 365 applications (Word, Excel, PowerPoint).
• Adaptability: Able to work in a fast-paced, dynamic environment and adjust to shifting priorities.
• Team Player: Ability to work collaboratively in a team-oriented environment.
• Solution-oriented mindset: Identifying and addressing issues as they arise.
• Language: Fluent in French & professional level in English; written and spoken communication skills are important.

Interested?

Send your motivation letter with curriculum vitae to: careers@cellistic.com