Quality Control Laboratory Receiving Data Associate
Summary
Manages sample receipt, data entry, and testing coordination in a regulated lab to ensure product quality and compliance with cGMP standards.
Work Schedule: Thursday–Monday | 3:00 p.m. – 11:30 p.m.
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.
- 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.
- High school diploma or GED required.
- 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.
- 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.
The physical requirements described below are representative of those that must be met to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform these essential functions.
- Ability to safely work with ingredients and products derived from common allergens, including nuts, soy, dairy, fish, and shellfish.
- Ability to remain in a stationary position and move throughout laboratory and manufacturing environments during scheduled shifts.
- Ability to stoop, kneel, crouch, crawl, and perform routine laboratory tasks as needed.
- Ability to communicate effectively with colleagues and read printed and electronic documentation, including small print.
- Ability to work in a moderate-noise laboratory environment.
- Ability to occasionally lift and move materials weighing up to 30 pounds.
- Ability to frequently reach overhead and perform repetitive movements with the arms and hands throughout the workday.
- Competitive compensation
- 100% company-paid medical, dental, and vision insurance coverage for employees
- Company-paid short- and long-term disability insurance
- Company- paid life insurance
- 401k plan with employer matching contributions up to 4%
- Gym membership reimbursement
- Monthly allowance of Thorne supplements
- Paid time off, volunteer time off and holiday leave
- Training, professional development, and career growth opportunities