QA Auditor II

Thermo Fisher Scientific•Middleton, WI

1d•Hybrid

About The Position

This is a hybrid role based at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. Join us as Quality Assurance Auditor II - And enhance our clinical auditing processes by ensuring regulatory compliance and quality standards.

Requirements

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
Thorough knowledge of GMP and appropriate regional research regulations and guidelines
Demonstrated proficiency and led a range of project based or internal GMP audits o high standards required by management
Excellent oral and written communication skills
Strong problem solving, risk assessment and impact analysis abilities
Solid experience in root cause analysis
Above average negotiation and conflict management skills
Flexible and able to multi-task and prioritize competing demands/work load
Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.

Responsibilities

Conduct and/or lead a variety of client, internal or GMP audits and regulatory inspections as requested by senior management
Perform directed site audits, and facility, audits
Provide GMP consultation and support to project teams and external clients
Lead process audits and may participate as a co-auditor in more complex system audits
Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
Serve as a knowledgeable resource to operational departments on audit or quality assurance subject matter
Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings