Job SummaryThe Manufacturing Operations and Compliance Specialist is responsible for supporting compliance activities within the manufacturing organization to ensure adherence to internal procedures, regulatory requirements, and quality standards. This role partners closely with Manufacturing, Quality, Engineering, Training, and Scheduling teams to coordinate compliance-related activities, track training metrics, and support investigations, CAPAs, change controls, and unplanned deviations (UPDs) related to manufacturing operations.
Area Of ResponsibilityKey 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.
- Support 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.
- Assist with 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.
- Support 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.
- Support 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 EstimateUp to 0 %
Education and Job Qualification - High School Diploma required; B.S. in related field preferred or equivalent experience
Experience- Minimum 5 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.
