Manufacturing Operation and Compliance Specialist
On-siteAll, Catalunya, Kingdom of Spain
Job Summary
Coordinate with cross-functional departments including Manufacturing, Quality, Engineering, and Training to support compliant manufacturing operations and ensure adherence to internal procedures and regulatory requirements. Act as a compliance liaison for manufacturing activities, tracking training metrics, monitoring overdue training, and supporting remediation efforts. Support the initiation, tracking, and closure of Corrective and Preventive Actions (CAPAs), change controls, and unplanned deviations, ensuring proper documentation, investigation, and implementation. Maintain accurate records within quality management systems, support new equipment qualification activities, and update Master Batch Records. Ensure compliance with cleanroom requirements, including gowning and environmental controls, while reviewing artworks, labels, and packaging components for accuracy. Works under direct supervision to prioritize responsibilities and assist on the production floor if required.
Required Qualifications
- Working knowledge of GMP, quality systems, and regulatory requirements.
- Experience supporting CAPAs, change controls, and deviation management.
- Strong organizational and coordination skills with the ability to manage multiple priorities.
- Proficient in documentation systems and basic data tracking/reporting tools.
- High School Diploma required
- Minimum 5 years or more of related experience supporting Manufacturing or Quality Departments
Desired Qualifications
- B.S. in related field preferred or equivalent experience
- Experience in pharmaceutical, biotech, medical device, or other regulated manufacturing environments.
- Familiarity with electronic Quality Management Systems.
- Experience tracking training compliance metrics.
- Knowledge of root cause analysis tools and continuous improvement practices.
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