Compliance Specialist - Manufacturing

About the role

The Compliance Specialist supports manufacturing projects, quality systems, computer systems, and continuous improvement initiatives within the manufacturing department.

Responsibilities

• Coordinate project completion
• Revise and approve manufacturing procedures
• Lead investigations
• Manage change control records
• Assess process performance
• Assist in training and validation
• Participate in regulatory inspections
• Contribute to tech transfer and process improvements
• Represent manufacturing on cross-functional teams, collaborating with QA, QC, Engineering, Validation, and others

Requirements

• BA/BS in a scientific field or equivalent
• 2-5 years of experience in biopharmaceutical manufacturing
• Familiarity with computer systems (OpCenter, ERP, EBR, Veeva)
• Knowledge of GMP and regulatory standards
• Strong communication and organizational skills
• Proficiency in Microsoft Office
• Ability to work evenings, weekends, and holidays
• Ability to gown for manufacturing areas

Preferred Qualifications

• Lean Six Sigma certification
• Root cause analysis experience
• Laboratory skills
• Experience in ISO 7 cleanrooms