QA Auditor II

Thermo Fisher Scientific • Middleton, WI

1d

About The Position

Join us as Quality Assurance Auditor II - And enhance our clinical auditing processes by ensuring regulatory compliance and quality standards. What You’ll Do: Conduct and/or lead a variety of client, internal or GxP audits and regulatory inspections as requested by senior management Perform directed site audits, facility, vendor and/or sub-contractor audits Provide GxP 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

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’). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Thorough knowledge of GxP and appropriate regional research regulations and guidelines
• Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to 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
• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.

Responsibilities

• Conduct and/or lead a variety of client, internal or GxP audits and regulatory inspections as requested by senior management
• Perform directed site audits, facility, vendor and/or sub-contractor audits
• Provide GxP 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level