GMP QA Auditor I - Data Integrity & Compliance

ThermoFisher Scientific; Town of Middleton (WI); Hybrid; USD 55,000 - 75,000; Full time

Job summary

Thermo Fisher Scientific in Middleton, WI, invites applicants for a hybrid QA Auditor I role. The position focuses on routine QA audits of GMP-lab data, documentation review for GMP compliance, and collaboration with laboratory teams to ensure timely data release.

Qualified candidates have a Bachelor’s degree or equivalent, with 1 year of lab/QA experience. Strong attention to detail and solid documentation skills are essential for success.

Qualifications

• Bachelor's degree or equivalent; Associates acceptable in lieu.
• 1 year lab or QA experience or equivalent.
• Equivalency may combine education, training, and related experience.

Responsibilities

• Conduct routine QA audits of GMP lab data and documentation.
• Review data for compliance with GMP requirements and procedures.
• Document audit observations and communicate findings to lab personnel.
• Collaborate with lab teams to resolve audit observations and complete QA reviews.
• Perform routine facility inspections for GMP compliance.
• Support QA activities including reviews and process-related improvements.
• Maintain accurate QA documentation and data integrity.

Skills

GMP knowledge

Attention to detail

Communication skills

Analytical thinking

Time management

Independent work

Cross-functional teamwork

Education

Bachelor's degree or equivalent

Associate degree acceptable in lieu

Job description

Thermo Fisher Scientific in Middleton, WI, invites applicants for a hybrid QA Auditor I role. The position focuses on routine QA audits of GMP-lab data, documentation review for GMP compliance, and collaboration with laboratory teams to ensure timely data release.

Qualified candidates have a Bachelor’s degree or equivalent, with 1 year of lab/QA experience. Strong attention to detail and solid documentation skills are essential for success.