What are the responsibilities and job description for the QA Lab Oversight Specialist II position at Legend Biotech?
Legend Biotech is seeking QA Lab Oversight Specialist I/II/III as part of the Quality team based in Raritan, NJ.
Role Overview
The QA Lab Oversight Specialist role is an exempt level position with responsibilities for providing quality oversight over the site Quality Control laboratories responsible for testing of pre-clinical, clinical, and commercial stage CAR-T cellular therapy products. This role will be responsible for reviewing and approving, of standard operating procedures (SOPs), validation/ qualification/ method transfer protocols, completed assay data and reports primarily for the quality control laboratories.
Key Responsibilities
Legend Biotech maintains a drug-free workplace.
Benefits:
Role Overview
The QA Lab Oversight Specialist role is an exempt level position with responsibilities for providing quality oversight over the site Quality Control laboratories responsible for testing of pre-clinical, clinical, and commercial stage CAR-T cellular therapy products. This role will be responsible for reviewing and approving, of standard operating procedures (SOPs), validation/ qualification/ method transfer protocols, completed assay data and reports primarily for the quality control laboratories.
Key Responsibilities
- Be responsible for providing quality oversight for site Quality Control laboratories responsible for testing pre-clinical and clinical and commercial stage CAR-T cellular therapy products in accordancewith Janssen policies, standards, procedures, and Global cGMP.
- Work with QC organization to support the successful transfer of QC Lab functions to the Raritan cGMP facility to test products.
- Review and approval of standard operating procedures.
- Review and approve Validation/Qualification/Method Transfer protocols, completed Assay Data and Reports.
- Review and approve Completed Daily Assay Data, Gown/Pipette Qualifications, Generated Reports and CoA's as applicable.
- Support the release of documentation pertaining to the release of patient sample materials.
- Perform spot-checks in the QC Laboratories to ensure compliance with written regulations, policies, procedures, and global procedures.
- Strive to reduce non-conformances in supported areas by proactively driving compliance.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Critically support investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.
- Recognize patterns and trends in reported data and communicate to management.
- Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consults with Supervisor/Manager for decisions outside establishedprocesses.
- Provide guidance to other employees in the interpretation of quality issues and participates in the development of technical or scientific initiatives and activities.
- Routinely recognize and resolve quality issues. Seeks management guidance on complex issues.
- Be able to interpret complex results and situations with degree of independence and articulate recommendations for solutions. Identifies risk and develops contingency plans.
- Act as liaison for the quality team in support of site improvement projects and strategies.
- Be a Subject Matter Expert on quality assurance topics within the group in support of QC lab activities.
- Detailed knowledge of CAR-T QC test methods and related equipment is preferred
- Perform other duties that will be assigned, as necessary.
- Key Relationships: works in a collaborative team setting with quality counterparts that include all Quality Control Departments including QC Critical Reagents, QC Release, QC IPL, and QC Lab Services.
- A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
- A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
- Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceutical. Experience in supporting cell-based products as well as knowledge of Good Tissue Practices is a plus.
- Strong interpersonal and written/oral communication skills.
- Ability to quickly process complex information and often make critical decisions with minimal oversight.
- Proficient in applying process excellence tools and methodologies.
- Ability to independently be responsible for a portfolio of ongoing projects.
- Ability to pay attention to details and follow the procedures.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a requirement.
- Ability to work with others in a team environment.
- Detailed knowledge and understanding of current Good Manufacturing Practices(cGMP). Knowledge of current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing is a plus.
- Ability to identify/remediate gaps in processes or systems.
- Experience with cell and/or gene therapy analytical technique (e.g. flowcytometry, qPCR)
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
- Language: English
Legend Biotech maintains a drug-free workplace.
Benefits:
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Matched 401K
- Flexible Spending Account
- Health Savings Account
- AD&D Insurance
- Short-Term Disability
- Long-Term Disability
- Paid Maternity Leave
- Paid Paternity Leave
- Pet Insurance
- Critical Illness Insurance
- Hospital Indemnity Insurance
- Accident Insurance
- Legal Insurance
- Commuter Benefits
- Employee Assistance Program
