Compliance Specialist
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Job Summary
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
- Associates or Bachelors 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
