QA Shop Floor Specialist II

Legend Biotech • Raritan, NJ

126d

About The Position

Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. 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.

Requirements

• Bachelors degree required in Life Sciences or Engineering.
• 4+ years Biotech/Pharmaceutical experience or equivalent industry experience.
• Must have 2 years of relevant quality experience working 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.
• Ability to lift 20 lbs.
• Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems.
• Good written and verbal communication skills are required.

Nice To Haves

• Experience with quality support in clinical manufacture.
• Ability to summarize and present results, and experience with team-based collaborations.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products.
• Great attention to detail and ability to follow the procedures.
• Ability to manage conflict and issues that arise with internal or external customers.

Responsibilities

• Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.
• Supervise manufacturing and manufacturing support activities for cGMP compliance through spot checks/internal audits.
• Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing issues.
• Real time review of all documentation, and reporting, in support of process unit operations, in accordance with Good Documentation Practices (GDP).
• Review, revise, or draft Standard Operating Procedures (SOPs).
• Support on process aseptic process simulations of the processes to ensure sterility of the product/process is not compromised.
• Support material release in SAP for In-house reagents.
• Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Support Investigations team by providing quality and compliance input for continuous improvement and remediations.
• 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.
• Provide QA shop floor support for extended periods of time.
• 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.

Benefits

• Medical, dental, and vision insurance.
• 401(k)-retirement plan with company match that vest fully on day one.
• Equity and stock options available to employees in eligible roles.
• Eight weeks of paid parental leave after just three months of employment.
• Paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays.
• Flexible spending and health savings accounts.
• Life and AD&D insurance.
• Short- and long-term disability coverage.
• Legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• Commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree