QC Lab Services Specialist - Sample Control & Compliance

Socket.dev

Raritan (NJ)

On-site

USD 63,000 - 83,000

Full time

11 days ago

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Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Job summary

Legend Biotech in Raritan, NJ is seeking a QC Specialist, Lab Services I to join the US Quality team. You will manage sample custody, retains, and coordinate shipments while supporting regulatory audits and cGMP adherence.

The role requires a Bachelor's degree and at least 2 years of related experience in biopharma or medical devices, with familiarity with LIMS and quality systems; weekend/evening shifts and up to 5% travel may be required.

Qualifications

Bachelor's degree or higher in Biology, Biochemistry, Microbiology, Chemistry or related field.
At least 2 years of related experience in medical device, biopharmaceutical, or pharmaceutical industry.
Solid understanding of regulatory requirements, policies and guidelines.
Experience with QC document reviews and regulatory inspection processes.

Responsibilities

Prepares and reviews documentation independently.
Responsible for QC sample and retain management.
Knowledge of cGMP related to the QC laboratory and ability to identify gaps in processes or systems.
Proficient with Microsoft Office and LIMS.
Prepare documents and coordinate sample shipments.