Quality Assurance Specialist, Cellistic

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Plaats

Mont-Saint-Guibert
1435
Waals-Brabant
België

Contract

Vooltijds, Onbepaalde duur

Datum gepubliceerd

2025-06-26

Online to:

2025-08-25
EUR 20.00 HOUR

Quality Assurance Specialist

Cellistic
Waals-Brabant
1 dag geleden

About the Company - Cellistic is growing, and we’re looking for passionate team members who believe in the power of engineered cells as medicines, challenge the status quo, and thrive on bringing novel ideas to life.About the Role - We are seeking a detail-oriented and reliable Quality Assurance (QA) Specialist to support our growing biotech operations. The focus of this role will be to play a key role in maintaining and improving the Quality assurance system to support GMP operations related to iPSC manufacturing. The QA Specialist 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. This position will support, material qualification, equipment qualification, quality documents review and approval, and day-to-day QA operations.ResponsibilitiesEnsure the appropriate good manufacturing practices (GMP) guidelines are implemented in Cellistic quality management systemCoordinate the material qualification programParticipate in the equipment qualification/validation as QA review and approvalParticipate in the design, implementation, and continuous improvement of Quality Management Systems (QMS)Participate in inspection and audit readiness programMonitor and edit the quality management system of Cellistic with KPIDraft, Review and approve comprehensive documentation, including standard operating procedures (SOPs), protocols, reports and quality items (change control, Event, CAPA)Participate in the development and delivery of GMP training programs to staffAct as Quality SME for quality items (e.g. deviation, CAPA)Provide support to the quality operations activitiesProvide support to risk analysis and coordinate when needed risk managementParticipate in audit programPromote Quality MindsetQualifications - Master degree in Pharmaceutical Sciences, Biology, Chemistry, Biomedical Sciences, Biotechnology Engineer or equivalent through experienceRequired SkillsAt least 3-5 years' experience in quality assurance function within pharmaceutical or biotechnology industryExpertise in GMP and pharmaceutical industry standards, GMP for ATMP is an assetExpertise in deviation, CAPA management and audit executionExperience in iPSC, biologics, or cell therapy is an assetPreferred SkillsExcellent interaction communication skills, required to work across departmentsHighly developed organizational skillsWriting skillsAbility to work in fast-growing and agile environmentFlexible mindset capable to deal with ambiguity and to respond quicklySelf-motivated, enthusiastic personality, team playerProblem solverLanguages: Fluent in English and French – Minimum Level B2Proficient knowledge of Office 365 applications (Word/Excel/Access/PPT)Application Process:Interested candidates should submit their resume and cover letter outlining qualifications and experience to careers@cellistic.com.Cellistic is an equal opportunity employer committed to creating an inclusive environment for all employees.

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