QA Auditor II

Thermo Fisher Scientific • Richmond, VA

12d • Onsite

About The Position

The QA Auditor II supports Thermo Fisher Scientific’s BIOA Lab in Richmond, Virginia, in a fully onsite role. The position enhances clinical auditing processes by ensuring regulatory compliance and quality standards. The role is part of PPD Laboratory Services, which provides laboratory services in support of clinical research and patient health. Applicants must be legally authorized to work in the United States without sponsorship and pass a comprehensive background check, including drug screening.

The auditor conducts and leads client, internal, GxP, site, facility, vendor, subcontractor, process, and other quality assurance audits. The position also provides GxP consultation, supports project teams and external clients, advises operational departments on audit and quality matters, and presents audit findings to internal and client audiences. Work takes place in an office, laboratory, and/or clinical environment, with potential exposure to biological fluids and infectious organisms and required use of personal protective equipment. Business travel may be required.

Thermo Fisher Scientific describes its mission as enabling customers to make the world healthier, cleaner, and safer. The company offers a comprehensive U.S. Total Rewards package, including medical, dental, and vision plans; employee and family support programs; paid time off and holidays; parental leave; insurance and disability coverage; retirement savings; and an employee stock purchase plan.

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 or more years; an appropriate combination of education, training, and/or directly related experience may be considered equivalent in some cases.
• Thorough knowledge of GxP and applicable regional research regulations and guidelines.
• Demonstrated proficiency leading a range of project-based or internal GxP audits and vendor audits to management’s required 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.
• Ability to work upright and/or stationary for 6–8 hours per day; perform repetitive hand movements; maintain frequent mobility; occasionally crouch or stoop and frequently bend or twist the upper body and neck; and lift or carry objects, including luggage and a laptop, up to 15–20 pounds.
• Ability to use a variety of in-house and off-the-shelf computer software, communicate and understand spoken information, interact with diverse groups, handle variable tasks and changing conditions, perform under stress, and maintain regular and consistent attendance.

Responsibilities

• Conduct and/or lead client, internal, 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 work.
• 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

• Choice of national medical and dental plans and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off and 10 paid holidays annually.
• Paid parental leave: 3 weeks for bonding and 8 weeks for caregiver leave.
• Accident and life insurance, and short- and long-term disability coverage in accordance with company policy.
• Competitive 401(k) U.S. retirement savings plan.
• Employee Stock Purchase Plan offering eligible colleagues the opportunity to purchase company stock at a discount.
• May be eligible for a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

What This Job Offers

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