The Role
Manage quality processes including product certification, CAPA, deviations, nonconforming material, customer complaints, internal audits, SOP updates, and stability testing coordination. Liaise with third-party certifiers and contract manufacturers, produce KPI and status reports, support GMP/FDA/OSHA compliance, and drive process improvements.
Summary Generated by Built In
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, you’ll 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.
The Quality Associate I supports Thorne's Quality Management System (QMS) by assisting with quality processes, documentation, and compliance activities that help ensure products consistently meet company, customer, and regulatory requirements. This role provides operational support for key quality systems, including product certifications, Change Control, Corrective and Preventive Actions (CAPA), deviations, customer complaints, nonconforming materials, and document control.
The Quality Associate I supports Thorne's Quality Management System (QMS) by assisting with quality processes, documentation, and compliance activities that help ensure products consistently meet company, customer, and regulatory requirements. This role provides operational support for key quality systems, including product certifications, Change Control, Corrective and Preventive Actions (CAPA), deviations, customer complaints, nonconforming materials, and document control.
Working closely with Quality, Operations, Regulatory Affairs, Product Development, and Supply Chain, the Quality Associate I develops a strong foundation in quality systems while contributing to continuous improvement initiatives and daily quality operations. The ideal candidate is detail-oriented, highly organized, and eager to learn within a regulated manufacturing environment while building expertise in GMP requirements and quality management processes.
RESPONSIBILITIES
- Support the administration of Thorne's Quality Management System (QMS), including Change Control, Corrective and Preventive Actions (CAPA), Deviations, Nonconforming Materials (NCM), customer complaints, and document control activities.
- Assist in coordinating third-party product certification activities by gathering documentation and communicating with certification bodies, contract manufacturers, and internal stakeholders.
- Support the stability program by coordinating sample submissions, maintaining documentation, and assisting with stability data collection and reporting.
- Assist with customer complaint investigations by collecting information, documenting findings, and supporting timely resolution.
- Maintain, organize, and update quality documentation, including Standard Operating Procedures (SOPs), controlled forms, and quality records.
- Participate in internal audits and inspections while supporting audit preparation and follow-up activities.
- Assist in reviewing new products, processes, and documentation to help ensure compliance with GMP requirements and internal quality standards.
- Generate routine quality reports, KPI metrics, and status updates to support quality system monitoring.
- Complete ERP and ETQ transactions related to quality processes and maintain accurate electronic records.
- Collaborate with cross-functional teams to support quality initiatives and continuous improvement efforts.
- Maintain compliance with GMP, FDA, OSHA, and all applicable company policies and regulatory requirements.
- Escalate quality concerns or potential compliance issues to appropriate team members and support timely resolution.
- Perform other duties as assigned.
WHAT YOU NEED
Education & Experience
- High school diploma or GED required; Associate's or Bachelor's degree in a scientific discipline, Quality, Manufacturing, or a related field preferred.
- 0–2 years of experience in Quality Assurance, Manufacturing, Laboratory Operations, Regulatory Affairs, or a related field preferred.
- Internship, co-op, or experience within a GMP-regulated manufacturing environment is a plus.
- Familiarity with quality management systems or regulated manufacturing environments is preferred.
Technical Knowledge
- Basic understanding of Good Manufacturing Practices (GMP) and quality system principles.
- Ability to interpret Standard Operating Procedures (SOPs), work instructions, and technical documentation.
- Proficiency with Microsoft Office Suite and willingness to learn ERP and electronic Quality Management Systems (eQMS), such as ETQ.
- Ability to prepare accurate documentation, reports, and quality records.
Core Competencies
- Strong attention to detail and commitment to accuracy.
- Excellent organizational and time management skills with the ability to prioritize multiple assignments.
- Strong verbal and written communication skills.
- Ability to work collaboratively in a cross-functional team environment while developing independent decision-making skills.
- Demonstrated initiative, curiosity, and a willingness to learn new quality systems and regulatory requirements.
- Analytical problem-solving skills with the ability to recognize and escalate quality concerns appropriately.
- Adaptability and a commitment to continuous improvement in a fast-paced manufacturing environment.
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
About
We specialize in delivering innovative solutions and exceptional services to meet the diverse needs of our clients. With a strong commitment to quality and customer satisfaction, we strive to exceed expectations and drive success in every project we undertake.
Skills Required
- High school diploma
- College degree
- Knowledge of Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs)
- Experience managing Deviation and Nonconforming Material processes using EtQ
- Experience completing ERP functions related to NCM process
- Ability to assist with customer complaint investigations and CAPA management
- Experience supporting stability programs, coordinating sample submissions, and compiling stability reports
- Ability to participate in internal audits and write/revise SOPs and controlled documents
- Strong verbal and written communication skills and attention to detail
- Ability to work independently, manage projects, meet deadlines, and drive process improvements
- Familiarity with regulatory requirements including FDA, OSHA and company safety policies
- Proficiency with required equipment and software to perform quality responsibilities
Am I A Good Fit?
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The Company
What We Do
We’re a team of dreamers, scientists, doctors, and health enthusiasts – all working toward the same goal – helping every individual discover and achieve their best possible health. We do it by creating innovative health solutions and by owning every process, from R&D to product delivery and customer service. We intend to defy expectations of good health through home testing technology, dietary and lifestyle education, and superior nutritional products.
