Specialist, Label Control and Material Operations in Devens, MA

Role Summary

The Label Control and Material Operations role supports site operations at Devens in accordance with cGMP policies and procedures. It involves performing final drug product label printing and ensuring accurate, timely operations to support manufacturing and supply chain activities for Cell Therapy Development and Operations. Shifts available: 6am - 6pm, rotating schedule including holidays and weekends. Location: Devens, MA.

Responsibilities

• Issue clinical and commercial final drug product labels
• Verify the legibility and accuracy of drug product labels in accordance with approved procedures and label specifications
• Ensure areas are maintained in state of compliance to always be ready for health authority inspection or audits
• Perform basic troubleshooting; communicate and resolve discrepancies independently and escalate as required
• Author and review department owned documents
• Maintain compliance with assigned learning plan
• Support integration of newer team members
• Support internal and external inspections as required
• Assess discrepancies for entry into quality system and initiate deviations as applicable
• Participate in cross-department and cross-functional meetings, communicate in professional manner and share data/ knowledge within team. Build relationships with specialized functions

Qualifications

• 2+ years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Experience with quality management systems preferred.
• Experience with electronic systems and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP) preferred.
• Experience with labeling software and commercial label printers preferred.

Skills

• Ability to understand, follow and apply approved procedures
• Proficient computer skills with knowledge of MS Office
• Ability to understand problems and propose practical solutions
• Ability to communicate effectively with cross functional peers and various levels of cross functional management through written and verbal skills
• Ability to work in a fast-paced team environment with changing priorities
• Detail oriented and task focused with ability to meet deadlines and prioritize assigned work
• Active listening skills and ability to understand varied perspectives
• Ability to independently make decisions and recognize the need for escalation of issues
• Ability to seek out opportunities for improvement

Education

• Bachelor's degree preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.