QC Specialist, Lab Services I

Legend Biotech; Raritan (NJ); On-site; USD 63,000 - 83,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Parental leave

Paid time off

Job summary

Legend Biotech in the United States seeks a QC Specialist, Lab Services I to join the US Quality team based in Raritan, NJ. The role focuses on sample management and independent documentation review within a cGMP QC laboratory environment.

The candidate will have a Bachelor's degree, at least two years in pharma/biotech, and experience with eLIMS and QC document reviews, with willingness to work weekend/evening shifts and travel up to 5%.

Qualifications

• Bachelor’s degree or higher.
• Two years related experience in medical device, biopharmaceutical, or pharmaceutical industry.
• Degree in Biology, Biochemistry, Microbiology, Chemistry or related field.
• Solid understanding of regulatory requirements, policies and guidelines.
• Experience with Quality Control document reviews and regulatory inspection processes.
• Working knowledge of Quality systems.
• Experience in management of retain samples using electronic systems (eLIMS).
• Shifts include weekend and evening work as required by the manufacturing process.
• This position will be located in Raritan, NJ and may require up to 5% of travel.
• This position will occasionally require to lift up to 20 pounds.

Responsibilities

• Prepares and reviews documentation independently.
• Responsible for QC sample and retain management.
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS).
• Prepare documents and coordinate Sample shipment (internal and external shipments).
• Review logbooks and/ or LIMs to align physical quantities of samples in freezers/refrigerators.
• Periodic inspection and consolidation of retains.
• Document and perform sample management related non-conformance investigations.
• Document and handle corrective and preventative action records.
• Supports internal and regulatory audits.

Skills

Quality control documentation

Regulatory inspections

Analytical thinking

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree

Biology/ Chemistry related field

Tools

LIMS

MS Office

Job description

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a QC Specialist, Lab Services I as part of the US Quality team based in Raritan, NJ.

Role Overview

The QC Specialist, Lab Services, is responsible for sample management. The QC Specialist is encouraged to work independently on routine tasks and have conceptual understanding of all Quality Control functions and business areas. May need supervision/support to resolve some sophisticated issues. He/ She will serve as technical specialist within job function. Thinks logically and acts decisively.

Key Responsibilities

• Prepares and reviews documentation independently.
• Responsible for QC sample and retain management.
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS).
• Prepare documents and coordinate Sample shipment (internal and external shipments).
• Review logbooks and/ or LIMs to align physical quantities of samples in freezers/refrigerators.
• Periodic inspection and consolidation of retains.
• Document and perform sample management related non-conformance investigations.
• Document and handle corrective and preventative action records.
• Supports internal and regulatory audits.

Requirements

• A minimum of a Bachelor’s degree or higher.
• A minimum of two (2) years related experience in medical device, biopharmaceutical, or pharmaceutical industry.
• A degree in Biology, Biochemistry, Microbiology, Chemistry or related field.
• Solid understanding of regulatory requirements, policies and guidelines.
• Experience with Quality Control document reviews and regulatory inspection processes.
• Working knowledge of Quality systems.
• Experience in management of retain samples using electronic systems (eLIMS).
• Candidates must be able to accommodate shift schedule. Shifts include weekend and evening work as required by the manufacturing process.
• This position will be located in Raritan, NJ and may require up to 5% of travel.
• This position will occasionally require to lift up to 20 pounds.

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles

.Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays.

Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay): $63,298 USD - $83,077 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

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

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