Cell Therapy Quality Assurance Specialist
About The Position
The Cell Therapy QA Specialist supports the production of cellular products in cGMP ISO7 and ISO8 cleanroom manufacturing spaces, as well as controlled laboratory and warehouse areas. The role provides on-floor quality assurance support, manages documentation, supports raw material and product disposition, reviews and approves deviations, CAPAs, and change controls, and oversees material and product storage and distribution. The Specialist helps ensure GMP compliance, aseptic processing, and appropriate cleanroom behavior; supports environmental monitoring and manufacturing activities; reviews batch records; and contributes to audits, regulatory inspections, investigations, training, and process improvement. The role works collaboratively with internal and external teams and supports the company’s safety, GMP, and Quality Plan.
Requirements
- Degree in biology or a related field, or an equivalent combination of education, training, and/or experience.
- At least 5 years of industry experience in a GMP quality or manufacturing environment.
- Understanding of adherent cell culture processes.
- Knowledge of aseptic technique, cleanroom gowning, and GMPs.
- Understanding of applying FDA, EMA, and other regional requirements in a GMP manufacturing environment.
- Experience drafting and revising controlled documents.
- Experience with deviations, CAPA, and change control.
- Ability to calculate cell concentrations, seeding densities, percent viability, weights, and volumes.
- Ability to identify potential equipment or process issues.
- Ability to organize information across multiple concurrent projects.
- Interpersonal skills to establish and maintain professional relationships internally and externally.
- Ability to collaborate with internal and external cross-functional teams.
- Critical thinking, creativity, and innovative thinking.
- Attention to detail and ability to set priorities and organize daily work.
- Ability to work both independently and as a team member.
- Clear and precise written and oral professional communication skills.
- Ability to keep management informed about compliance and operational issues.
- Flexibility to adapt to changing production priorities, timelines, and processes.
- Integrity and discretion in maintaining confidentiality.
- Ability to perform under pressure.
- Ability to stand for long periods, gown for cleanroom work, work in a warehouse environment, and communicate clearly; may need to lift 20 pounds.
Nice To Haves
- Cell culture and aseptic processing experience preferred.
- Biotechnology certificate valued but not required.
Responsibilities
- Adhere to GMP guidelines and train team members on them.
- Provide on-floor support to manufacturing staff, understand manufacturing steps in batch production records, and recognize when deviations or incidents must be documented.
- Ensure aseptic processing techniques and appropriate cleanroom behavior are followed.
- Perform room and line clearances in support of the manufacturing schedule.
- Wear cleanroom gowns when working in a cleanroom.
- Support facility environmental monitoring processes and assist with troubleshooting.
- Write and revise SOPs, BPRs, and other quality- and compliance-related documents.
- Review completed batch records for GMP compliance and completeness, and compile information for disposition.
- Prepare for and manage client audits and regulatory inspections.
- Participate in CAPA teams, assist with investigations and root cause analysis, and verify actions are implemented and effective.
- Escalate issues to management, troubleshoot, and develop solutions.
- Maintain client confidentiality.
- Assist subject matter experts with training new and existing employees.
- Support and participate in research and investigational studies as needed.
- Provide feedback and support for drafting and implementing departmental documents and procedures for development and process improvement.
- Collaborate with internal and external cross-functional teams.
- Support and participate in the Excellos Labs safety, GMP, and Quality Plan.
- Participate in department meetings and educational programs.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
