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Thorne · 5 days ago

Regulatory Business Systems Analyst- REMOTE

United States

Full-time

Remote

Mid Level

$31.25/hr - $31.25/hr

3+ years exp

Thorne is a leader in science-backed health and wellness solutions, and they are seeking a Regulatory Business Systems Analyst to serve as a liaison between business units and technical support personnel. This role involves interpreting business goals into deliverables, providing application support, managing user access, and ensuring compliance with regulatory requirements for quality-supported software.

Dietary SupplementsHealth CareHealth DiagnosticsNutrition

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)

Qualification

FDA regulated environmentSoftware validationApplication supportQuality Management systemsProcess improvementAttention to detailCollaboration

Required

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

Preferred

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

Benefits

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

Company

Thorne

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.

Founded in 1984

New York, New York, USA

201-500 employees