Scientist III (Quality Control Specialist)

Thermo Fisher Scientific seeks a Scientist III Quality Control Specialist to lead analytical and microbiological quality control activities for pharmaceutical development and manufacturing. The role involves managing test method lifecycles, change controls, specifications, and quality system documentation in support of the Drug Product Division.

Responsibilities

• Evaluate and approve analytical data; lead quality initiatives and mentor junior team members
• Manage method lifecycle activities including gap assessments, transfer, qualification, and validation
• Assess compendial updates and author revision protocols with associated quality system changes
• Own change controls for test procedures, specifications, and raw material manufacturer changes
• Author and maintain quality documents including protocols, SOPs, specifications, and policy documentation

Requirements

• Bachelor's degree in Chemistry, Biology, Microbiology, or related physical science
• Minimum 8 years of quality control, analytical testing, or pharmaceutical manufacturing experience
• Strong knowledge of GMP, GLP, data integrity, and controlled documentation systems
• Proficiency with analytical techniques including HPLC, GC, LC/MS, dissolution, and spectroscopy
• Experience with change control, technical transfer, specification management, and risk assessment
• Advanced problem-solving and cross-functional collaboration skills
• Excellent written and verbal communication abilities