Investigations Supervisor Job Raritan area,New Jersey USA,Quality Assurance

Company

Legend Biotech is a global biotechnology company dedicated to treating and one day curing life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy.

Job Title

Investigations Supervisor

Job Duties

Support the area manager and work closely with investigators to ensure investigations are completed on time and as per guidelines.

Assign investigations to team members and track them to completion.

Follow up with investigators on status of investigations, corrections, CPAs and effectiveness checks.

Perform investigations and train new investigators.

Collaborate with the team to determine if corrective actions adequately addressed root cause of NC events.

Support tracking of deviations, events and key process parameters and provide reports to management on trending and status as requested.

Identify and implement process improvements related to safety, environmental, quality, compliance, productivity, yield and cost.

Implement process improvements within the change control system.

Recognize and act on potential compliance issues and opportunities for process changes or improvement.

Partner with all stakeholders to implement process improvements.

Assure regulatory compliance and technical feasibility of proposed changes.

Serve as project manager for the change process and provide coordination to ensure timely and compliant implementation of process improvements.

Serve as subject‑matter expert in preparation for and during internal and external regulatory audits (including FDA, EMEA).

Maintain various databases of production information.

Support coordination of data collection and trend analysis as requested by QA and Regulatory Affairs, including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR).

Review and approve SOP and batch record revisions.

Minimum

Job Requirements

Education:

Bachelor’s degree in Engineering, Science, or a related field.
Experience:

3 years as a Lead Engineer.
Special

Skills:

Operate eLIMS, Track Wise, Maximo, EMS, BMS, and SAP systems.

Job Site

1000 US-202, Raritan, NJ 08869

Work Hours

9:00 a.m. to 5:00 p.m., 5 days, 40 hours per week

Salary

$ per year.

Benefits and Paid Time Off

Medical, dental, and vision insurance; 401(k) retirement plan with company match; eight weeks of paid parental leave after three months of employment; vacation, personal, sick, floating holidays, and eleven company holidays. Additional voluntary benefits including flexible spending and health savings accounts, life and AD&D insurance, disability coverage, and supplemental plans such as pet and critical illness. Commuter benefits, family planning resources, well‑being initiatives, and peer recognition programs are also available.

Benefits apply exclusively to permanent full‑time employees; contractors are not eligible for benefits.

EEO Statement

Legend Biotech provides equal employment opportunities without regard to race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender, gender identity or expression, sexual orientation, marital status, military service, veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws.

Employment is at‑will and may be terminated at any time by either the employee or the company.

For information related to our privacy notice, please review the Legend Biotech Privacy Notice.

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