Quality Control Analyst

About – Here at Scienta we are teaming up with a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. They are developing advanced cell therapies across a diverse array of technology platforms – with a main focus on Oncology + Immunology.

The QC Analyst, is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

Main Responsibilities –

• Responsible for the completion of QC testing related to the manufacturing of Cell Therapy products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
• Work with Process Development team, Quality and Operations organisation to successfully transfer. process/analytical testing to cGMP facility to manufacture products.
• Utilise electronic systems (LIMS) for execution and documentation of testing.
• Create, review, and approve relevant QC documents, SOP’s and WI’s.
• Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.

Experience –

A Minimum of 1-2 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.

• Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
• The candidate must be highly organised and capable of working in a team environment with a positive attitude under some supervision.
• Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.

Why Apply?

If you are looking to work within a challenging, dynamic, and rewarding environment, then this represents the ideal role for yourself. This is an opportunity to be a part of an extremely well established Biotech which is guaranteed for career progression and exceptional knowledge to be gained.

Please submit your resume to us for a private and confidential discussion about the opportunity.