Support daily LIMS operation, maintenance, and improvement in a cGMP-regulated environment. Provide hands-on support for system configuration, troubleshooting, validation execution, and end-user assistance. Collaborate with the system vendor for system configuration and troubleshooting issues.
Key Highlights
Technical Skills Required
Benefits & Perks
Job Description
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.
Position Summary: The LIMS Specialist supports the daily operation, maintenance, and continuous improvement of the Laboratory Information Management System (LIMS). This role provides hands-on support for system configuration, troubleshooting, validation execution, documentation, and end-user assistance in a cGMP-regulated environment. Supports coordination with the system vendor for system configuration and troubleshooting issues, data reporting, authoring SOPs, and ensuring system cGMP compliance for the Quality Systems and QC Laboratory functions.
This is a remote role.
Responsibilities
- Provides day-to-day Tier 1 support for LIMS users, including issue triage, troubleshooting, and resolution under guidance of senior LIMS staff. Escalates complex issues to senior LIMS staff.
- Assists with approved system configuration activities such as test setup, workflows, templates, and master data updates under guidance of senior LIMS staff.
- Supports the implementation of new or revised methods, workflows, or processes to meet or improve QA and QC Laboratory operations.
- Assists in the updates to outward-facing Certificates of Analysis (OFCOA); supports OFCOA template validation.
- Supports improvement initiatives related to laboratory workflows, system usability, and efficiency.
- Assists in the creation and maintenance of SOPs, work instructions, and training materials related to LIMS.
- Supports the design and implementation of new or revised methods, workflows, or processes to meet or improve QA and QC Laboratory operations.
- Serves as Subject Matter Expert (SME) to assist and provide support to end users for new/existing software functions and/or modules as they apply to LIMS (Laboratory Information Management System) and other systems used in QA and Quality Control.
- Assists in the updates to outward-facing Certificates of Analysis (OFCOA); supports OFCOA template validation.
- Supports Excel data validation.
- Supports software validation activities in QA and the QC Laboratories.
- Ensures compliance with software testing and validation requirements.
- Ensures data integrity standards.
- Supports staff training prior to the implementation of new systems, changes and modifications to the systems as needed, with QA/QC Lab Management approval.
- Supports software validation activities, including execution of approved IQ/OQ/PQ protocols.
- Assists in drafting validation documentation, test scripts, and evidence packages.
- Participates in system upgrades, enhancements, and improvement projects as assigned.
- Ensures compliance with cGMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policies and procedures.
- Troubleshoots or carries out actions per scheduled or unscheduled maintenance.
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- High school diploma or GED required.
- Experience with computer systems with at least one year providing support in a technical environment is required.
- Associate or bachelor’s degree coursework in Life Sciences, Information Technology, Computer Science, or a related field preferred.
- 0–2 years of experience in a laboratory, quality, technical support, or regulated environment preferred.
- Prior exposure to LIMS or laboratory systems is a plus but not required.
- Experience with programming languages desirable.
- Possesses strong analytical skills with demonstrated problem-solving ability.
- Works independently with little direction in a fast-paced environment.
- Has knowledge of Microsoft products such as Word, Excel, Visio and Power Point as well as the ability to learn other computer system.
- Has knowledge or ability to learn of project software (i.e., Go To Meeting, Zoom, Microsoft Team).
- Has knowledge or ability to learn scripting and markup languages (i.e., SQL, JavaScript, HTML).
- Has knowledge or ability to learn reporting software (i.e., Tableau, Qlik).
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- 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
THORNE IS AN EQUAL OPPORTUNITY EMPLOYER
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