Band 5 Compliance Specialist II

Band 5 Compliance Specialist II role at Thermo Fisher Scientific's Plainville facility focuses on leading manufacturing investigations, root cause analysis, and CAPA management within viral vector production. The position owns deviation investigations, develops quality standards, and manages GxP documentation in a 100% onsite environment.

Responsibilities

• Conduct, assemble, and present GxP deviation investigations with root cause analysis and impact assessment
• Define, own, and support corrective and preventive actions aligned with manufacturing requirements
• Edit cGMP documents and manage workflow for quality-approved documentation creation
• Maintain tracking systems for manufacturing compliance priorities and support change control
• Collaborate cross-functionally with manufacturing and quality teams on continuous improvement initiatives

Requirements

• 2-4 years biopharmaceutical deviation investigation experience
• High school diploma with 6-8 years industry experience, or Associate's degree with 4-6 years, or Bachelor's degree with 2-4 years
• Proficiency with personal computers and business software applications
• Strong written and oral communication skills with diverse stakeholders
• Detail-oriented with ability to manage multiple priorities simultaneously
• Ability to gown aseptically in GMP manufacturing environments
• Capability to work effectively in fast-paced, dynamic operational settings

Compensation: $67,400–$101,150 base