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Compliance Coordinator
Blueroot Health™. Lead the qualification, evaluation, and continuous monitoring of all third-party contract manufacturers.
Tech Stack
Tools & technologiesERP
About the role
Key responsibilities & impact- 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.
- 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.
- 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.
- 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.
- 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.
- Verify lab results meet product specifications; follow up when results deviate or require deeper investigation.
- Analyze quality and performance data from co-mans to identify trends, risks, or process improvement opportunities.
- Maintain records and summaries for customer complaints requiring QA review, including Adverse Events (AEs) and Serious Adverse Events (SAEs).
Requirements
What you’ll need- 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.
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Paid time off
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Hard Skills & Tools
FDA cGMPdietary supplement complianceMaster Manufacturing Records (MMRs)Batch Production Records (BPRs)Certificates of Analysis (CoAs)SOP managementdata analysisquality assuranceregulatory affairstechnical documentation
Soft Skills
attention to detailindependent workcommunicationproblem-solvingproject managementorganizational skillscross-functional collaborationanalytical thinkingtime managementrisk assessment
Certifications
project management certificationFDA site registrationthird-party certificationsNSF certification