- Company Name
- Lexeo Therapeutics
- Job Title
- Contract Quality Control Research Associate
- Job Description
-
Job title: Contract Quality Control Research Associate
Role Summary: Coordinate sample management for CMC Quality Control, ensuring timely and accurate testing, data organization, and compliance with regulatory standards.
Expectations: Efficiently manage sample submission, shipping, tracking, and documentation; maintain LIMS accuracy; support vendor and lab testing activities; adhere to GMP/GxP, IATA RCA, and DOT guidelines.
Key Responsibilities
- Act as primary contact for QC lab support, including inventory, sample submission, and receipt.
- Prepare and submit paperwork for external contract labs (quotes, purchase orders, shipping docs).
- Coordinate shipment of samples, standards, and reagents to manufacturing sites, vendors, and CTLs under storage/shipping requirements.
- Track testing from submission to completion; receive, organize, and file CoAs, CoTs, and QC data packages.
- Ensure vendor testing documentation is complete and organized.
- Configure and maintain LIMS for CTU inventory and sample tracking.
- Enter and manage sample data, ensuring accurate labeling, barcoding/QR codes, and electronic record alignment.
- Collaborate with cross‑functional CMC teams on sample submission and testing needs.
Required Skills
- Bachelor’s degree in Chemistry, Biology, Biotechnology, or related scientific discipline.
- Practical experience in pharmaceutical/biotech QC, sample management, or logistics; knowledge of lab safety.
- Familiarity with IATA RCA and DOT shipping guidelines (preferred).
- Proficient with LIMS and laboratory sample tracking systems (e.g., Benchling, Quartzya).
- Strong organizational and detail orientation; ability to manage multiple priorities and meet deadlines.
- Excellent communication and coordination abilities.
- Understanding of GMP/GxP sample handling, testing, and documentation requirements.
Required Education & Certifications
- Bachelor’s degree in a scientific field (Chemistry, Biology, Biotechnology).
- Certifications in GMP/GxP or related quality systems preferred.