Quality Control Laboratory Receiving Data Associate
Job Location:
Summerville, SC - USA
Monthly Salary:
Not Disclosed
Posted on:
3 days ago
Vacancies:
1 Vacancy
Job Summary
At Thorne we work to deliver high-quality science-backed solutions to empower individuals to take a proactive approach to their well-being. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. At Thorne youll be joining a team of more than 750 passionate individuals committed to our cause of providing superior health solutions at every age and life stage.
Work Schedule: ThursdayMonday 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.
Work Schedule: ThursdayMonday 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.
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.
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.
WHAT YOU NEED
Education & Experience
- 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.
Technical Knowledge
- 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.
Core Competencies
- 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.
Physical Demands
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.
WHAT WE OFFER
- 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
Required Experience:
IC
About Company
We believe good health could always be made better. Shop Thorne's complete line of integrated health solutions