Quality Operations Specialist

Thermo Fisher Scientific seeks a Quality Operations Specialist for their Cincinnati pharmaceutical manufacturing site. The role involves ensuring quality standards and regulatory compliance in oral solid dose production, including deviation management, batch monitoring, and GMP compliance across a 12-hour shift environment.

Responsibilities

• Serve as QA point of contact for quality events, facilitating investigation path-forward and deviation report generation
• Author clear deviation reports and partner with cross-functional teams to ensure investigation conclusions align with GMP expectations
• Perform in-process QA checks prior to batch initiation including equipment functionality, training verification, and GMP documentation
• Support change control activities, hold tag management, manufacturing barrier checks, and annual Fit & Finish audits
• Provide consultation on process comments and maintain safe working environment while reporting hazards

Requirements

• High school diploma or GED with 5 years quality experience in GMP facility, or bachelor's in life sciences/chemistry/biology/engineering with 2 years quality experience
• Quality assurance or operations experience within GMP pharmaceutical, biotech, or medical device environment
• Strong knowledge of cGMP, GDP, and FDA/EMA regulatory expectations
• Understanding of pharmaceutical manufacturing processes and cleanroom operations
• Strong written and verbal communication with attention to detail and documentation accuracy
• Batch record review experience preferred
• SAP or ERP system familiarity preferred