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Regulatory Business Analyst- REMOTE

Thorne Research Inc • Full-time • Remote (United States) • $60k / year • 1m ago

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: At Thorne, the Regulatory Business Systems Analyst is more than a translator between business needs and technology. This role is a strategic partner, ensuring our regulated systems not only meet compliance standards but also empower our teams to thrive. The Analyst acts as the bridge between business stakeholders and technical and validation teams, transforming goals and challenges into actionable solutions while driving successful delivery of stakeholder objectives. This role provides expert application support by troubleshooting issues, coordinating resolutions, and keeping our quality-supported and regulated systems running seamlessly. The Analyst also evaluates vendor software updates and patches, assesses risk, and ensures smooth and compliant adoption, while managing user access and security to safeguard system integrity across the organization. In addition, this position leads compliance activities by conducting data integrity checks and 21 CFR Part 11 audits to keep systems audit-ready, and it oversees the validated state of regulated software throughout its lifecycle, ensuring change control and validation procedures are followed at all times. This position is ideal for someone who thrives at the intersection of compliance, technology, and problem solving, and who is motivated to ensure that Thorne’s quality systems not only meet regulatory requirements but also support innovation, efficiency, and our mission to push the boundaries of wellness.

This is a remote position.

Responsibilities

Becomes thoroughly knowledgeable of the applicable portions of Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) and maintains knowledge base on an ongoing, timely basis as procedural changes occur without relying on management intervention or direction.
Becomes thoroughly knowledgeable of the Standard Operating Procedures (SOPs) for computerized software.
Ensures compliance with cGMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
Adheres to company safety requirements.
Proactively initiates the development of streamlined systems to effectively identify and resolve quality problems and process improvement opportunities.
Assists in internal audits and inspections of various departments/processes.
Demonstrates knowledge of department procedures and company policies, pays attention to detail in all aspects, and completes all paperwork accurately, neatly, and fully.
Participates on process improvement teams to provide quality software compliance input and direction. Ensures that documentation of improvements is completed and approved as needed.
Builds a strong working relationship with department stakeholders and subject matter experts when dealing with requirements for software business processes that impacts software maintained by the Quality departments (Quality Assurance and Quality Control).

What You Need

High school diploma or general education degree (GED) is required.
A minimum of 3 years of Business/Technical analyst experience in an FDA regulated environment manufacturing environment is required.
A minimum of 1-3 years of experience in validating computer systems is required.
Experience in an FDA regulated environment and familiarization with Quality Management processes, systems and terminology preferred.
Experience with software development life cycle preferred.
Experience with Quality Management, Laboratory Information Management, Learning Management, Manufacturing, and Electronic Batch Records software systems.

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

Data Analyst

20h ago

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