Regulatory Compliance Analyst

DUTIES AND RESPONSIBILITIES:

• Plan, schedule, and conduct internal GMP audits across all departments to verify compliance with company procedures, FDA regulations, and customer requirements. Document findings, issue audit reports, and track CAPA completion.
• Support and host customers, third-party, and regulatory audits (FDA, NSF, UL, etc.). Coordinate pre-audit preparation, manage document requests, and ensure effective communication and closure of audit observations.
• Monitor, interpret, and communicate applicable regulations and guidance affecting dietary supplement manufacturing, labeling, and distribution—especially those impacting liquid formulations.
• Evaluate and improve processes related to documentation control, training, supplier qualification, deviation/CAPA management, and product release to ensure compliance alignment.
• Track and report progress of corrective and preventive actions (CAPAs) resulting from audits and non-conformances. Verify timely closure and ensure sustainable compliance improvements.
• Collaborate with Production, Quality Control, R&D, and Supply Chain teams to proactively identify compliance risks and implement mitigation measures.
• Participate in compliance training, audit program enhancement, and readiness initiatives to foster a culture of quality and regulatory excellence.
• Track and report CGMP and Quality related KPIs on a routine basis.

QUALIFICATIONS:

• Two years related regulatory/ compliance experience in a manufacturing environment.
• Experience with FDA and other regulatory agencies.
• Regulatory experience with dietary supplements, foods, OTC’s and/or personal care products, and the corresponding Codes of Federal Regulation is required.

 COMPETENCIES:

• Auditing: Skilled in planning, conducting, and documenting internal and external audits with objectivity and attention to detail.
• Analytical and Critical Thinking: Ability to analyze complex compliance data, identify root causes, and develop practical corrective and preventive actions (CAPAs).
• Technical Writing: Strong capability to write clear, concise, and compliant reports, SOPs, and audit responses suitable for regulatory and customer review.
• Communication and Interpersonal: Excellent verbal and written communication skills; able to interface professionally with FDA, NSF, and customer auditors under high-pressure situations.
• Project Management: Competent in managing multiple compliance projects simultaneously, maintaining organized documentation, and meeting deadlines.
• Data Management: Proficient in using digital QMS platforms, Microsoft Office Suite, and Excel-based audit tracking tools.
• Training and Coaching: Ability to provide compliance training and promote a culture of quality awareness across functional departments.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

• Continually required to sit
• Continually required to utilize hand and finger dexterity
• Occasionally required to climb, balance, bend, stoop, kneel or crawl
• Continually required to talk or hear
• Continually utilize visual acuity to read technical information, and/or use a keyboard
• Frequently required to lift/push/carry items 10 pounds to 25 pounds
• Occasionally work around fumes, airborne particles, or toxic chemicals
• Frequently exposure to extreme heat or cold (non-weather)
• Frequently/Continually exposure to moderate noise