Quality Assurance Specialist

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 specific focus on Immunology and Oncology.

The QA Specialist role is an exempt level position with major responsibilities for providing quality oversight over the production of a cell therapy to support both clinical and commercial requirements in a sterile GMP environment.

Duties –

Main Responsibilities –

• Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.
• Perform analysis on quality indicating data and identifying trends.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with manager for decisions outside established processes.
• Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
• Routinely recognize and resolve quality issues. Seek management guidance on complex issues.

Experience –

A minimum of ~2 years of industry experience is required. Your main responsibilities will be –

• Knowledge of cGMP regulations and FDA/EU guidance relating to Cell Therapies.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Proficient in applying process excellence tools and methodologies.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP).
• Ability to identify/remediate gaps in processes or systems.
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 is necessary and 600, 601, and 610 is preferred.

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.