QA Shop Floor Specialist II

About the role

The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.

Responsibilities

• Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.
• Support manufacturing activities for cGMP compliance through spot checks/internal audits.
• Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.
• Review of all documentation, in accordance with Good Documentation Practices (GDP).
• Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised.
• Support batch review & material release in SAP for In-house reagents.
• Support Floor Spot-check, audit trail review.
• Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor.
• Utilize multiple electronic quality systems, batch records and SAP.
• Work in a team based, cross-functional environment to complete tasks required to meet business objectives.
• Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas.
• Support regulatory inspections and audits as needed.
• Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements.

Requirements

• Bachelor’s degree required in Life Sciences or Engineering.
• 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience.
• Relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy.
• Experience with quality support in clinical manufacture is preferred.
• Flexible to work on weekends, as needed.
• Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
• Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning.