REGULATORY BUSINESS SYSTEM ANALYST

We are looking for top of market talent to help grow and innovate our company. If you are someone who embraces challenge, fosters innovation, and desires to make a difference in the world, then let's talk.

At Thorne we make products that matter - ones that make people's lives better. 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. As a self-motivated Production Lead you'll be joining a team of more than 700 passionate individuals committed to our cause of providing superior health solutions.

POSITION SUMMARY: The Regulatory Business System Analyst serves as the liaison between the business units and technical and validation support personnel. This position interprets the stakeholders' business goals into specific deliverables and understands challenges and develops solution options. The Regulatory Business System Analyst oversees that the stakeholders' business goals have been delivered and accepted. This position provides application support by troubleshooting reported issues and coordinating the applied resolution for all Quality supported and or/or regulated company used software. The Regulatory Business System Analyst reviews and develops risk assessment for vendor scheduled software upgrades and patches for Quality supported and regulated software used by Thorne. This position manages user access and security for all Quality supported software and performs system data integrity and 21 CFR Part 11 compliance audits on Quality supported software. This position maintains the validated state of all regulated software ensuring change control, and validation procedures are followed for the software's life cycle and audit readiness.

RESPONSIBILITIES - Satisfactorily performing and/or achieving the following Responsibilities are essential duties of the job.

• 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.

• Demonstrates initiative and job knowledge by suggesting ideas, discovering new and better ways of accomplishing goals, and finds innovative, thought-out solutions to problems.

• 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).

• Builds a strong working relationship with department software administrators to ensure regulatory compliance of regulated software.

• Identifies, analyzes, and evaluates risks for process improvements.

• Other duties as assigned.

What You Need:

• Experience and/or Education: By training, education and/or experience, employee must be able to perform the essential duties of the job. High school diploma or general education degree (GED) is required. 3+ years of Business/Technical analyst experience in an FDA regulated environment manufacturing environment, 1-3 years of experience in validating computer systems.

• 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:

At Thorne, we offer employees the chance to work with great people on exciting projects, with opportunity for growth. We also provide a full range of benefits for you and your eligible family members, such as:

• Competitive compensation

• 100% company-paid medical, dental, and vision insurance coverage

• 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

• A safe and clean work environment

A little bit more about us.

We are committed to providing personalized health solutions, cutting-edge home health test technology, and superior supplements. To do that, Thorne owns every step of its business, from R&D to product delivery and customer service. Currently, we are:

• The only company with exclusive partnerships with the Mayo Clinic and U.S. Olympic teams.

• The #1 prescribed practitioner brand to 30 to 40-year-olds.

• The #2 most dispensed supplement brand.

• The fastest growing supplement company with sales on Amazon; the #1 practitioner brand; with an average ranking of 4.42 of 5 stars.

This is a Non-Exempt (hourly) position

If you want to make a difference in the lives of others consider becoming part of the Thorne team.

Must be able to safely work with ingredients and products that are derived from possibly allergenic sources including, but not limited to, nuts, soy, dairy, fish, and shellfish.

THORNE IS AN EQUAL OPPORTUNITY EMPLOYER

Thorne values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, sexual orientation, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.