Manufacturing Operation and Compliance Specialist

Job Summary

Area Of Responsibility

Key Responsibilities include:

• Collaborate with cross-functional departments including Manufacturing, ILP, Quality Assurance, Engineering, Plant Services, Scheduling, Procurement, Materials Management, Warehouse, and Training to support compliant and efficient manufacturing operations.
• Serve as the primary compliance liaison for manufacturing and ILP activities, facilitating timely communication, issue resolution, and adherence to quality system requirements.
• Coordinate manufacturing readiness activities for regulatory audits, customer inspections, and internal quality reviews.
• Manage training programs for Manufacturing and ILP personnel, ensuring qualification status, training compliance, and alignment with production schedules.
• Monitor training metrics, track overdue requirements, and support remediation efforts to maintain workforce qualification and regulatory compliance.
• Lead and support the initiation, tracking, investigation, and closure of Corrective and Preventive Actions (CAPAs), ensuring effective implementation and sustainability of corrective measures.
• Support Temporary Change Controls and Unplanned Deviation (UPD) investigations, including root cause analysis, risk assessment, and alignment with CAPA actions.
• Coordinate change control activities impacting manufacturing processes, equipment, materials, and documentation, ensuring timely assessment, approval, implementation, and training completion.
• Maintain accurate records within electronic quality management systems and support the creation, review, and revision of manufacturing quality documentation.
• Track and report key compliance and operational metrics to management, providing visibility into training, CAPA, deviation, and quality system performance.
• Support equipment qualification activities through protocol execution, documentation review, and production readiness assessments.
• Update, review and maintain Master Batch Records (MBRs) for Production and ILP operations to ensure compliance with current processes, equipment, and regulatory requirements.
• Ensure compliance with cleanroom standards, environmental controls, gowning requirements, and GMP regulations; provide cleanroom training and maintain associated records.
• Review and approve artwork, labels, and packaging components within the Artwork Management System (AMS) to ensure accuracy, compliance, and alignment with approved specifications.
• Perform On-the-Job Training (OJT) as a PAC Trainer, mentoring and qualifying Manufacturing and ILP personnel.
• Serve as backup to the Manufacturing & ILP Supervisor, supporting daily operations, personnel coordination, and departmental objectives.
• Demonstrate strong organizational, communication, and leadership skills with the ability to effectively manage multiple priorities in a fast-paced GMP manufacturing environment.

Additional responsibilities as assigned

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.