Requirements: English
Company: Cellistic
Region: Mont-Saint-Guibert , Walloon Region
About the Company - Cellistic is growing, and were 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.
Responsibilities
- Ensure the appropriate good manufacturing practices (GMP) guidelines are implemented in Cellistic quality management system
- Coordinate the material qualification program
- Participate in the equipment qualification/validation as QA review and approval
- Participate in the design, implementation, and continuous improvement of Quality Management Systems (QMS)
- Participate in inspection and audit readiness program
- Monitor and edit the quality management system of Cellistic with KPI
- Draft, 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 staff
- Act as Quality SME for quality items (e.g. deviation, CAPA)
- Provide support to the quality operations activities
- Provide support to risk analysis and coordinate when needed risk management
- Participate in audit program
- Promote Quality Mindset
Qualifications - Master degree in Pharmaceutical Sciences, Biology, Chemistry, Biomedical Sciences, Biotechnology Engineer or equivalent through experience
Required Skills
- At least 3-5 years'' experience in quality assurance function within pharmaceutical or biotechnology industry
- Expertise in GMP and pharmaceutical industry standards, GMP for ATMP is an asset
- Expertise in deviation, CAPA management and audit execution
- Experience in iPSC, biologics, or cell therapy is an asset
Preferred Skills
- Excellent interaction & communication skills, required to work across departments
- Highly developed organizational skills
- Writing skills
- Ability to work in fast-growing and agile environment
- Flexible mindset capable to deal with ambiguity and to respond quickly
- Self-motivated, enthusiastic personality, team player
- Problem solver
- Languages: Fluent in English and French Minimum Level B2
- Proficient 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.