Contract Quality Control Research Associate na Lexeotx

The Contract QC Research Associate will support the CMC Quality Control (QC) function by coordinating all aspects of sample management(including, but not limited to: storage, documentation, submission, and shipment) to internal and external testing laboratories. This role ensures timely and accurate execution of sample testing activities to support product release, stability programs, and other analytical requirements. Additionally, this role will help organize, trend, interpret, and summarize the data resulting from testing. 

Primary Responsibilities

Serve as primary contact for QC Lab Support processes such as laboratory inventory management,  sample submission, sample receiving.. 

Prepare and manage sample submission paperwork for external contract testing labs (CTLs), including quotes, purchase orders, shipping documents. 

Coordinate shipment of samples, reference standards, and reagents to and from manufacturing sites, external vendors, and CTLs in compliance with storage and shipping requirements. 

Track sample testing from submission through completion; receive and organize Certificates of Analysis (CoAs), Certificates of Testing (CoTs), and other QC data packages. 

Coordinate with vendors and support vendor testing activities by ensuring report documentation packages are complete and organized. 

 Configure and maintain the LIMS system to support controlled temperature unit (CTU) inventory and sample tracking requirements. 

Enter and manage sample data in LIMS; ensure accurate labeling, categorization, and documentation. 

Generate sample labels with unique identifiers (e.g., barcodes or QR codes) and ensure physical organization of samples in alignment with electronic records. 

Collaborate with cross-functional CMC teams to align on sample submission and testing needs. 

Required Skills & Qualifications

Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Biotechnology) 

Hands on experience in pharmaceutical/biotech QC, sample management, or logistics with an understanding of lab safety; knowledge of IATA RCA and DOT guidelines a plus 

Experience with LIMS and laboratory sample tracking systems; familiarity with Benchling or Quartzya plus. 

Strong organizational skills with attention to detail and accuracy. 

Ability to manage multiple priorities and meet deadlines in a fast-paced environment. 

Excellent communication and coordination skills. 

Knowledge of GMP/GxP requirements for sample handling, testing, and documentation preferred. 

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