Investigations Supervisor

Legendcareers; Raritan (NJ); On-site; USD 129,416 - 158,175; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

Paid time off policy

Voluntary benefits including flexible spending and health savings accounts

Job summary

Legendcareers is seeking an Investigations Supervisor to support the area manager and work with investigators to ensure investigations are completed on time and per guidelines. You will assign investigations, perform oversight, and ensure regulatory compliance.

The ideal candidate will have a Bachelor's degree in Engineering, Science, or a related field, as well as 3 years of experience as a Lead Engineer. The position offers a comprehensive benefits package including insurance, 401(k), and paid parental leave.

Qualifications

• 3 years as a Lead Engineer experience required.

Responsibilities

• Support area manager and work closely with investigators to ensure timely investigations.
• Assign investigations to team members and track them to completion.
• Perform investigations and train new investigators.
• Recognize and act on potential compliance issues.

Skills

Operate eLIMS

TrackWise

Maximo

EMS

BMS

SAP systems

Education

Bachelor's degree in Engineering, Science, or a related field

Job description

Company

Legend Biotech USA, Inc.

Job Title

Investigations Supervisor

Job Duties

1. Support area Manager and work closely with investigators to ensure investigations are completed on time and as per guidelines.
2. Assign investigations to team members and track them to completion
3. Follow up with investigator on status of investigations, Corrections, CPAs and Effectiveness checks.
4. Perform investigations and train new investigators.
5. Collaborate with team to determine if corrective actions adequately addressed root cause of NC event.
6. Support tracking of deviations, events and key process parameters and provides reports to management on trending, and status as requested.
7. Identify and implement process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost.
8. Implement process improvements within the change control system.
9. Recognize and act on potential compliance issues and opportunities for process changes/improvement.
10. Partner with all stakeholders to implement process improvements.
11. Assure regulatory compliance and technical feasibility of proposed changes.
12. Serve as project manager for the change process and provide coordination to ensure timely and compliant implementation of process improvements.
13. Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
14. Maintains various databases of production information.
15. 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).
16. 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, TrackWise, 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 hr/wk

Salary

$143,796.12 /yr.

Benefits

Medical, dental, and vision insurance; 401(k) retirement plan with a company match; paid parental leave; paid time off policy; additional voluntary benefits including flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance; voluntary commuter benefits; family planning and care resources; well-being initiatives; peer-to-peer recognition programs.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment Terms

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.