QC Specialist, Lab Services I

Legend Biotech US•Raritan, NJ

9d•$63,298 - $83,077•Onsite

About The Position

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

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.
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.

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.

Benefits

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