QA Laboratory Compliance Specialist III

Legend Biotech is seeking a QA Laboratory Compliance Specialist III as part of the Quality team based in Raritan, NJ.

Role Overview

The QA Lab Compliance (QALC) specialist III role is an exempt level position with responsibilities for providing quality and compliance oversight over all functions of the Quality Control Laboratories responsible for testing Advanced therapy products. QALC will work in a collaborative team setting with quality counterparts that include all Quality Control Departments including QC Release, QC IPL, QC Micro, QC Lab Services and QC Investigations.

Key Responsibilities

• Work in close collaboration with QC functional areas to provide QA oversight.
• Attend 1/1 meetings with QA supervisors.
• Train and coach Level I/II QALC when performing newer day-to-day activities.
• Oversight for QC laboratories to ensure quality, compliance, and adherence to global standards as well as regulatory requirements.
• Support Level I/II QALC by overseeing the completion of spot-checks for QC Laboratories to ensure compliance with written regulations, policies, procedures, and global procedures.
• Compliance oversight of all QC operations.
• Support the supervisor in managing cross-functional projects with QC Functional Area Owners.
• Perform ad-hoc walk-throughs of QC labs to ensure GMP is followed.
• Perform formbook reviews, UARs, SOP reviews, quarterly trend reports and spot checks.
• Work in collaboration with QA supervisor and QC Functional Areas to ensure the trends identified during the spot checks and walk-throughs are addressed.
• Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Be able to interpret complex situations with independence and articulate recommendations for solutions to QA management.
• Be a Subject Matter Expert on Quality Assurance topics within the group in support of QC lab activities.
• Support regulatory inspections and audits by ensuring QC functional areas are in an audit-ready state.

QC Investigations:

• Collaborate, provide QA insight and develop sound strategical approaches to complex investigations with cross functional team (Investigation Management and QC Functional Area Owners) to align on root cause, corrections, and CAPAs.
• Provide guidance to QC in the interpretation of quality issues.
• Monitor the lifecycle of the investigations assigned and ensure they are approved within the required timeframe.
• Ensure Corrections and CAPA actions are in place for the investigations and support the immediate/root cause of the investigation.
• Collaborate with QC Investigations team to ensure record closure timelines are being met.
• Attend the daily check-in meetings to provide status updates of the records assigned.
• Ensure the metrics spreadsheet is updated.
• Perform timely escalations of potential significant nonconformances to management.
• Attend escalation meetings with Supervisor and support the Supervisor in drafting escalation meeting minutes.
• Provide guidance to QC Functional Areas in the interpretation of Nonconformances and participate in remediation and continuous improvement at the site.
• Provide quality oversight on checkpoint and Rapid Response calls for prompt initiation of quality issues.
• Participate in QALC weekly meetings. Share investigation learnings and best practices to maintain and drive overall quality mindset.
• Support regulatory inspections and audits by presenting in the front room for the investigations requested.
• Collaborate with QC Release, QC IPL, QC Micro, QC Lab Services and QC Investigations.

Requirements

• A minimum of a Bachelors Degree in Science, or equivalent technical discipline is required.
• A minimum of 2 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, quality control, manufacturing compliance, clinical quality, or cell therapy.
• A minimum of 1 year experience in QA.
• Strong knowledge of Nonconformance and CAPA management process.
• Knowledge of cGMP/cGLP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceutical. Experience in supporting cell-based products as well as knowledge of CAR-T cell therapy.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Proficient in applying process excellence tools and methodologies.
• 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
• Good written and verbal communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP). Knowledge of CAR-T manufacturing or cell processing is a plus.
• Ability to identify/remediate gaps in processes or systems.
• Experience reviewing GMP documentation including but not limited to: SOPs, Work Instructions, Investigations, CAPAs, Change Controls
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
• This is primarily an On-Site role and required to be on-site all days of the week.

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