Job Summary
The Manufacturing 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 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.
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 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 3 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.
The presently-anticipated base compensation pay range for this position is $65,500 to $72,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
