Manufacturing Operation and Compliance Specialist

Job Summary

Area Of Responsibility

Key Responsibilities include:

• Coordinate with cross-functional departments including Manufacturing, Quality Assurance, Engineering, Plant Services, Scheduling, Procurement, Materials, Management, Warehouse and Training to support compliant manufacturing operations.
• Act as a compliance liaison for manufacturing activities, ensuring timely communication and issue resolution.
• Support manufacturing readiness for audits, inspections, and internal reviews.
• Coordinate manufacturing training activities in alignment with production schedules.
• Track, monitor, and report training metrics to ensure personnel are qualified and current on required training.
• Follow up on overdue or missing training and support remediation efforts.
• Lead the initiation, tracking, and closure of Corrective and Preventive Actions (CAPAs) related to manufacturing.
• Ensure CAPAs are appropriately documented, investigated, and implemented in accordance with quality system requirements.
• Monitor CAPA effectiveness and support trending and reporting activities.
• Lead change control activities impacting manufacturing processes, equipment, documentation, and materials.
• Ensure change controls are properly assessed, documented, approved, and implemented.
• Coordinate with stakeholders to ensure training and documentation updates are completed as part of change implementation.
• Lead documentation, tracking, and investigation of manufacturing deviations and Unplanned Deviations (UPDs).
• Ensure deviations are escalated, assessed, and resolved in a timely and compliant manner.
• Assist with root cause analysis and support alignment with CAPAs when required.
• Maintain accurate and compliant records within quality management systems.
• Creation, review, and updates of manufacturing-related quality documentation.
• Track compliance metrics and support periodic reporting to management.
• Support new equipment qualification activities, including protocol execution and documentation, to ensure readiness for production or ILP use.
• Update and maintain MBR (Master Batch Records) for both Production and ILP to reflect process changes and ensure effective, compliant use of equipment
• Ensure compliance with cleanroom requirements, including adherence to gowning, environmental controls, and regulatory standards.
• Coordinate and provide cleanroom-related training to employees working in controlled environments; maintain training records as per compliance requirements.
•  Review artworks, labels, and packaging components for accuracy, compliance, and alignment with approved specifications.
• Works under direct supervision and follows clearly described process and procedures
• Able to assist on the Production floor if required 

Able to multi task and prioritize responsibilities

Work Conditions:

• Office
• Lab
• Controlled areas

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.

Preferred Qualifications

• 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.

Travel Estimate

Up to     0   %

Education and Job Qualification

• High School Diploma required; B.S. in related field preferred or equivalent experience

Experience

• Minimum 8 years or more of related experience supporting  Manufacturing or Quality Departments
• Experience in pharmaceutical, biotech, medical device, or other regulated manufacturing environments.
• Familiarity with electronic Quality Management Systems (Track Wise, EDMS, Master Control).
• Experience tracking training compliance metrics.
• Knowledge of root cause analysis tools and continuous improvement practices.