Regulatory Business Systems Analyst- REMOTE

Thorne Research Inc

3d•Remote

About The Position

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 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 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. This is a remote position.

Requirements

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 is required.
A minimum of 1-3 years of experience in validating computer systems is required.
Knowledge of software validation for regulated software.
Experience with application support, including implementation of new software or improvements.

Nice To Haves

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 preferred.

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.
Collaborate with business stakeholders to understand and gather their requirements and identify opportunities for process improvement.
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).