PURPOSE STATEMENT:

The Regulatory Compliance Coordinator plays a critical role in ensuring all third-party contract manufacturers (co-mans) meet Blueroot Health’s strict quality, regulatory, and documentation standards. This role is responsible for evaluating, approving, and monitoring co-manufacturers and suppliers; ensuring adherence to cGMP for dietary supplements; reviewing and approving raw material and finished product specifications; and authorizing the release of finished goods for shipment to Blueroot Health warehouses.

This position is central to maintaining the integrity, safety, and quality of Blueroot Health’s product portfolios. The coordinator will manage all 3rd party manufacturing-related quality documentation (including that for and from raw material suppliers), oversee compliance of all production activity completed by third-party partners, and support regulatory readiness for certifications and inspections.

WHAT YOU’LL DO (MAJOR RESPONSIBILITIES):

1. Third-Party Manufacturer Oversight & Qualification

· Lead the qualification, evaluation, and continuous monitoring of all third-party contract manufacturers.

· Review and verify co-man compliance with FDA cGMP, NSF, and other certification bodies.

· Ensure each manufacturing partner operates within approved quality systems and meets Blueroot Health’s production, testing, and documentation standards.

· Maintain and update approved supplier/manufacturer qualification files, audits, and risk assessments.

· Act as primary Blueroot Health compliance liaison for co-man quality questions, deviations, documentation requests, and investigative follow-up.

2. Product Specification & Quality Documentation Management

· Review, manage, and approve all raw material specifications, blended batch specs, in-process specs, and finished product specifications.

· Ensure all raw materials, intermediates, and finished goods have validated and complete specification sheets aligned with regulatory expectations.

· Oversee receipt and verification of Certificates of Analysis (CoAs) from co-mans, ensuring completeness, accuracy, and compliance with specifications.

· Maintain active, accessible, organized files for all specifications, CoAs, and quality-related documentation.

3. Manufacturing Records & Release Authorization

· Prepare, manage, and review Master Manufacturing Records (MMRs) and Batch Production Records (BPRs) to ensure compliance prior to manufacturing release.

· Review all batch documentation from co-mans for completeness, deviations, testing results, and non-conformance investigations.

· Approve release of finished goods for shipment to Blueroot Health distribution centers once all quality requirements are met.

· Maintain traceability and complete lifecycle documentation for all manufactured products.

4. cGMP Compliance & Regulatory Preparedness

· Ensure all documentation required for dietary supplement cGMP compliance is current, accurate, and audit ready.

· Organize and support regulatory and certification inspections (FDA, NSF, State/Federal agencies).

· Maintain facility registration documentation (FDA site registration, state registrations, third-party certifications).

· Manage and update Standard Operating Procedures (SOPs), training records, and quality procedures related to co-manufacturing compliance.

5. Quality Investigations & CAPA Support

· Maintain active files for deviations, QC investigations, OOS reports, CAPAs, and other quality events.

· Coordinate with co-mans to ensure investigations are completed thoroughly and on time.

· Review and integrate CAPA outcomes into relevant records and processes.

· Maintain up to date documentation and controls of all master manufacturing records and batch production records as well as all finished product specifications defining production of all sku’s by and at 3rd party co-manufacturers.

6.Testing Coordination & Analytical Oversight

· Coordinate all third-party laboratory testing requirements, including raw materials, in-process testing, finished products, and shelf-life stability studies.

· Verify lab results meet product specifications; follow up when results deviate or require deeper investigation.

· Manage retained samples, stability data, and testing schedules.

7. Data, Reporting & Continuous Improvement

· Analyze quality and performance data from co-mans to identify trends, risks, or process improvement opportunities.

· Develop reports summarizing compliance findings, testing results, investigation activity, and quality metrics from third-party partners.

· Support compliance improvement initiatives, audit readiness, and process efficiency across the Regulatory function.

8. Customer Safety & Product Integrity

· Maintain records and summaries for customer complaints requiring QA review, including Adverse Events (AEs) and Serious Adverse Events (SAEs).

· Ensure investigations and documentation follow established regulatory timelines and reporting requirements.

WHAT YOU’LL NEED (KNOWLEDGE/SKILLS/EXPERIENCE):

· 2–3 years of experience in FDA-regulated functions including regulatory affairs or quality assurance, ideally in dietary supplements, medical nutrition/food and/or nutraceuticals.

· Experience working with third-party contract manufacturers strongly preferred.

· Strong working knowledge of dietary supplement cGMP (21 CFR Part 111).

· Ability to manage and interpret technical documentation such as MMRs, BPRs, CoAs, specifications, and analytical test reports.

· Experience managing SOPs, controlled documents, and quality systems.

· Strong data analysis skills and ability to identify opportunities for quality improvement.

· Excellent attention to detail and ability to work independently with minimal supervision.

· Strong communication and problem-solving skills across cross-functional teams.

· Project management experience or certification preferred.

· Experience with ERP systems, document control software, or quality management systems is a plus.

PHYSICAL REQUIREMENTS:

· Ability to sit for extended periods of time while maintaining focus and productivity.

· Perform repetitive tasks, including typing and data entry, and work for prolonged periods at a computer screen.

· Ability to travel occasionally for business needs, including attending meetings, trainings, or company events.

· Ability to maintain composure and professionalism in a fast-paced, high-demand work environment.

Blueroot Health™ is an Equal Opportunity Employer. Employment opportunities at Blueroot Health™ are based upon one’s qualifications and capabilities to perform the essential functions of a particular job. All employment opportunities are provided without regard to race, religion, sex, national origin, age veteran status, disability, genetic information, or any other characteristic protected by law.

This Equal Employment Opportunity policy governs all aspects of employment, including, but not limited to, recruitment, hiring, selection, job assignment, promotions, transfers, compensation, discipline, termination, layoff, access to benefits and training, and all other conditions and privileges of employment.