QA Auditor II

Thermo Fisher Scientific • Richmond, VA

1d • Onsite

About The Position

The QA Auditor II supports Thermo Fisher Scientific’s PPD Laboratory Services team and its BIOA Lab in Richmond, Virginia. This is a fully onsite role focused on enhancing clinical auditing processes and ensuring regulatory compliance and quality standards. The position conducts and leads client, internal, GxP, site, facility, vendor, and subcontractor audits, and may support regulatory inspections. It also provides GxP consultation to project teams and clients, contributes to audits of processes and other QA activities, advises operational departments, and presents audit findings. Applicants must be legally authorized to work in the United States without sponsorship and pass a comprehensive background check, including drug screening. The role involves work in an office, laboratory, and/or clinical environment, including potential exposure to biological fluids and infectious organisms, and requires personal protective equipment.

Requirements

• Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
• Previous QA experience providing the knowledge, skills, and abilities to perform the job, comparable to 2+ years.
• Thorough knowledge of GxP and applicable regional research regulations and guidelines.
• Demonstrated proficiency in, and experience leading, project-based or internal GxP audits and vendor audits to management standards.
• 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.
• Flexibility and ability to multitask and prioritize competing demands and workload.
• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel.
• Legally authorized to work in the United States without sponsorship.
• Ability to pass a comprehensive background check, including drug screening.

Responsibilities

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

Benefits

• Medical insurance plans
• Dental insurance plans
• Vision insurance plan
• Health incentive programs
• Employee assistance and family support programs
• Commuter benefits
• Tuition reimbursement
• At least 120 hours of paid time off
• 10 paid holidays annually
• Paid parental leave, including 3 weeks for bonding and 8 weeks for caregiver leave
• Accident insurance
• Life insurance
• Short- and long-term disability
• 401(k) retirement savings plan
• Employee Stock Purchase Plan with an opportunity to purchase company stock at a discount
• Variable annual bonus may be available based on company, team, and/or individual performance

What This Job Offers

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