Compliance Specialist

About the Role

The Compliance Specialist is responsible for maintaining documentation accuracy, regulatory compliance, and quality system integrity across manufacturing operations. This role supports batch record review, packaging documentation, ERP data management, change control processes, and regulatory requirements to ensure products are manufactured in accordance with company standards, customer requirements, and industry regulations. The ideal candidate is highly organized, detail oriented, and comfortable working with cross functional teams in a fast paced manufacturing environment.

Responsibilities

• Review and maintain Master Batch Records (MBRs), Batch Production Records (BPRs), packaging records, and supporting quality documentation
• Ensure manufacturing records are completed accurately, thoroughly, and in compliance with internal procedures and regulatory requirements
• Support document control activities including SOP creation, revisions, approvals, and archival processes
• Manage change control documentation and assist with implementation of process improvements
• Review production and quality records for completeness, accuracy, and compliance
• Support internal audits, customer audits, and regulatory inspections
• Investigate documentation discrepancies and partner with operations, quality, and production teams to resolve issues
• Maintain data integrity within ERP, inventory, and quality management systems
• Generate reports and perform data analysis using Excel, including pivot tables and compliance tracking metrics
• Assist with CAPA activities, deviations, nonconformances, and root cause investigations
• Support training documentation and ensure employee compliance with required procedures
• Promote adherence to GMP, food safety, quality, and regulatory requirements

Qualifications

• Associate's or Bachelor's degree in Quality, Food Science, Business, Life Sciences, or related field
• Experience in manufacturing compliance, quality assurance, document control, or regulated production environments
• Experience reviewing production records, batch records, packaging records, or quality documentation
• Familiarity with ERP systems and electronic documentation systems
• Proficiency in Microsoft Excel, including data analysis and pivot tables
• Strong attention to detail and organizational skills
• Ability to interpret procedures, specifications, and technical documentation
• Strong written and verbal communication skills

Desired Qualifications

• Experience within nutraceutical, dietary supplement, food, pharmaceutical, or regulated manufacturing environments
• Knowledge of GMP, FDA, SQF, HACCP, NSF, UL, BRCGS, or related standards
• Experience supporting audits, CAPA programs, deviations, and change controls
• Experience with inventory control, traceability, and quality management systems
• Lean Manufacturing, Six Sigma, CQI, HACCP, or PCQI certifications