QC Specialist, Lab Services I

Role Overview
The QC Specialist, Lab Services is responsible for sample management. Encouraged to work independently on routine tasks with conceptual understanding of all Quality Control functions and business areas; may need supervision/support to resolve sophisticated issues.

Key Responsibilities
- Prepares and reviews documentation independently.
- Responsible for QC sample and retain management.
- Apply knowledge of current cGMP in the QC laboratory; identify gaps in processes/systems.
- Proficient with Microsoft Office (Outlook, Excel, Word, PowerPoint) and LIMS.
- Prepare documents and coordinate sample shipment (internal and external).
- Review logbooks and/or LIMS to align physical sample quantities in freezers/refrigerators.
- Periodic inspection and consolidation of retains.
- Perform and document non-conformance investigations related to sample management.
- Document and handle corrective and preventative action (CAPA) records.
- Support internal and regulatory audits.

Requirements
- Bachelor’s degree or higher.
- 2+ 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 QC document reviews and regulatory inspection processes.
- Working knowledge of quality systems.
- Experience managing retain samples using electronic systems (eLIMS).
- Able to accommodate shift schedule (weekends/evenings as required).
- Located in Raritan, NJ; up to 5% travel; occasionally lift up to 20 pounds.