QC Specialist, Lab Services, II/III

Legend Biotech US•Raritan, NJ

10h•Onsite

About The Position

Legend Biotech is seeking a QC Specialist, Lab Services, II/III to join the Quality team in Raritan, NJ. This role is responsible for sample management within the Quality Control functions. The specialist will work independently on routine tasks and possess a conceptual understanding of all Quality Control functions and business areas, with potential need for supervision on more complex issues. The individual will serve as a technical specialist within their job function, thinking logically and acting 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.

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 insurance
Dental insurance
Vision insurance
401(k) retirement plan with a company match that vests fully on day one
Paid parental leave
Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays
Flexible spending accounts
Health savings accounts
Life insurance
AD&D insurance
Short-term disability coverage
Long-term disability coverage
Legal assistance
Supplemental plans such as pet insurance, critical illness insurance, accident insurance, and hospital indemnity insurance
Commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs