Legend Biotech US
QA Shop Floor Specialist II
Raritan, New Jersey, United States · Mid
Sponsorship not specifiedDetected 6 days ago
SAPSupply ChainCustomer SupportClinical TrialsGMPCommunicationCollaboration
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
- 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.
- 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.
- 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.
- 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.
Requirements
- Bachelor's degree required in Life Sciences or Engineering.
- 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience
- Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy.
- Is frequently required to communicate with coworkers.
- While performing the duties of this job, the employee is regularly required to stand
- Ability to lift 20 lbs.
Nice to have
- Experience with quality support in clinical manufacture is preferred.
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This listing is sourced directly from Legend Biotech US's careers page and normalized into a canonical job model.