Quality Control Data Associate
Thorne
- Summerville, United States
- On-site
- Entry Level
- Posted
Responsibilities
- Assemble, review, and maintain Quality Control laboratory data to support accurate product disposition and timely material release.
- Generate Certificates of Analysis (COAs) and other quality documentation in accordance with established procedures and regulatory requirements.
- Create purchase orders and coordinate analytical testing with outside contract laboratories (OCLs).
- Coordinate the submission, tracking, and completion of samples requiring external laboratory analysis, ensuring testing is completed accurately and on schedule.
- Review laboratory results received from contract laboratories, verify testing against approved specifications, and accurately enter data into the Laboratory Information Management System (LIMS).
- Verify that all required testing has been completed prior to forwarding receiving reports, batch records, and supporting documentation for Quality Assurance review.
- Develop and maintain proficiency with the Laboratory Information Management System (LIMS), product specifications, and quality documentation, including Finished Product Specifications (FPSs) and Raw Material Specifications (RMSs).
- Communicate with outside contract laboratories to coordinate testing priorities, expedite urgent analyses, and resolve testing or documentation inquiries.
- Support periodic reexamination and stability activities by coordinating required testing and maintaining accurate documentation.
- Maintain the integrity, confidentiality, and impartiality of laboratory data while identifying and communicating potential risks to laboratory operations or quality systems.
- Support compliance with ISO 17025 requirements by maintaining the integrity of the laboratory management system during planned changes and continuous improvement initiatives.
- Perform other duties as assigned.
Schedule
Tuesday–Saturday, 8:00 a.m. – 5:00 p.m.
Education & Experience
- High school diploma or GED required; Associate's or Bachelor's degree in Chemistry, Biology, Life Sciences, Quality, or a related scientific discipline preferred.
- Experience in a Quality Control laboratory, manufacturing, pharmaceutical, nutraceutical, food, or other GMP-regulated environment is preferred.
- Experience working with Laboratory Information Management Systems (LIMS), ERP systems, or laboratory data management is a plus.
- Familiarity with Certificates of Analysis (COAs), laboratory documentation, and quality records is preferred.
Technical Knowledge
- Basic understanding of current Good Manufacturing Practices (cGMP), laboratory documentation, and quality system requirements.
- Ability to interpret Standard Operating Procedures (SOPs), product specifications, and laboratory documentation.
- Proficiency with Microsoft Office Suite and the ability to quickly learn laboratory information systems and other quality-related software.
- Strong attention to detail with the ability to accurately review, verify, and maintain laboratory data and documentation.
- Basic mathematical skills and the ability to perform calculations required to support laboratory and quality processes.
Core Competencies
- 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 external laboratory partners.
- Demonstrated ability to work independently while exercising sound judgment and maintaining data accuracy.
- Strong analytical and problem-solving skills with the ability to identify discrepancies, raise concerns promptly, and support timely resolution.
- High level of integrity and commitment to maintaining confidential laboratory data and quality records.
- Positive, collaborative approach with a commitment to continuous improvement and operational excellence.
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
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