Quality Control Laboratory Receiving Data Associate

Thorne•Summerville, SC

14d•Onsite

About The Position

The QC Laboratory Receiving & Data Associate plays a critical role in supporting Quality Control laboratory operations by managing sample receipt, coordinating external laboratory testing, and ensuring the accuracy and integrity of laboratory data throughout the testing lifecycle. This role is responsible for receiving and tracking laboratory samples, generating Certificates of Analysis (COAs), reviewing Quality Control data, and supporting the timely release of raw materials, finished products, and other quality-controlled materials in accordance with established procedures and regulatory requirements. Working closely with Quality Control, Quality Assurance, Manufacturing, Warehouse Operations, and outside contract laboratories, the QC Laboratory Receiving & Data Associate helps ensure laboratory activities are completed accurately, efficiently, and in compliance with current Good Manufacturing Practices (cGMPs) and internal quality standards. The ideal candidate is highly organized, detail-oriented, and committed to maintaining data integrity, sample traceability, and operational excellence in a fast-paced laboratory environment.

Requirements

High school diploma or GED required.
Working knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and laboratory Standard Operating Procedures (SOPs), or the ability to quickly learn and apply them.
Ability to accurately enter, review, and maintain laboratory data while ensuring data integrity and sample traceability.
Proficiency with Microsoft Office applications and the ability to learn laboratory software, including LIMS.
Basic mathematical skills and the ability to interpret specifications, testing requirements, and laboratory documentation.
Ability to follow written procedures, prioritize tasks, and maintain accurate records in a regulated laboratory environment.
Strong attention to detail with a commitment to accuracy, quality, and regulatory compliance.
Excellent organizational and time management skills with the ability to manage multiple priorities and meet deadlines.
Strong verbal and written communication skills with the ability to collaborate effectively across Quality Control, Quality Assurance, Manufacturing, and Warehouse Operations.
Demonstrated ability to work independently while contributing to a collaborative team environment.
Proactive problem-solving skills with the ability to identify issues, communicate concerns promptly, and recommend practical solutions.
Commitment to maintaining confidentiality, impartiality, and the integrity of laboratory data.
Positive attitude with strong interpersonal skills and a customer-service mindset.

Nice To Haves

Experience in a laboratory, manufacturing, quality, warehouse, or other regulated environment is preferred.
Experience working in a cGMP-regulated environment or with laboratory quality systems is a plus.
Previous experience with Laboratory Information Management Systems (LIMS), Enterprise Resource Planning (ERP) systems, or other laboratory software is preferred.

Responsibilities

Receive, log, and route raw material, in-process, finished product, stability, and other laboratory samples to the appropriate Quality Control laboratory areas for testing.
Accurately enter and maintain sample information within the Laboratory Information Management System (LIMS), ensuring data integrity and traceability throughout the testing process.
Perform FT-NIR analyses on raw materials, in-process materials, and finished products in accordance with approved procedures and testing requirements.
Assemble and organize laboratory data to support Quality Control testing, documentation, and product disposition activities.
Verify that all required testing has been completed prior to forwarding batch records and supporting documentation for Quality Assurance review.
Utilize product specifications, including Finished Product Specifications (FPSs), Raw Material Specifications (RMSs), and other controlled documentation to support laboratory operations.
Monitor and maintain inventory levels of laboratory supplies, coordinating replenishment requests to ensure uninterrupted laboratory operations.
Maintain accurate laboratory documentation and records in accordance with Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP), and internal quality procedures.
Collaborate with Quality Control, Quality Assurance, Manufacturing, Warehouse Operations, and other cross-functional teams to support timely sample processing and product release activities.
Maintain a clean, organized, and inspection-ready work environment while supporting continuous improvement initiatives and performing other duties as assigned.
Maintain working knowledge of applicable Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and laboratory quality requirements, ensuring compliance with established procedures and regulatory standards.
Support compliance with ISO 17025 requirements by maintaining accurate laboratory records, following established quality procedures, and contributing to the integrity of the laboratory quality management system.
Maintain the confidentiality, impartiality, and integrity of laboratory data while promptly communicating potential quality or compliance concerns.