QA Auditor III - Client Audit Host

This is a fully onsite role based at our BIOA Laboratory in Richmond, VA. 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.

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovation.

The QA Auditor III

• Client Audit Host provides broad expertise to the department in one or more specialized areas or processes in the execution of the Quality Management System (QMS). This role involves leading and attending inter-departmental meetings related to their area of expertise to develop strategies and implementation plans. The Quality Assurance Specialist II serves as a client contact for company-contracted services for large or significant programs and contributes to policy-making decisions as a resource in their area(s) of expertise.

• Serve as subject matter expert for process/vendor audits or activities in several areas of expertise, e.g. review computer system validation data, lab investigations, root cause analysis, batch record review or total Quality Management.
• Represent the department in client and regulatory inspections/audits, and lead in development, lifecycle tracking, and effectiveness measurement of corrective actions.
• Provide training for department and/or laboratory staff.
• May lead risk assessments.
• Manage set up and filing of documents.
• May mentor junior team members in area(s) of expertise.

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ 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.

• Leads client and regulatory inspections. May lead vendor and internal audits, participate in client and regulatory inspections, and/or manage the administration and reporting aspects of quality management systems.
• Provides comprehensive expertise to the department covering one or more specialized quality management areas assuring all systems, processes and their outcomes comply with applicable international and national regulations
• Guidelines and fulfill client and company requirements
• Serves as quality consultant to the organization in their area(s) of GxP expertise
• Acting as a resource for training activities and policy-making decisions, supporting business leaders in mitigation of risk Being responsible for building relationships between on-site QA services and QA management of designated clients.

• Work is performed in an office, laboratory environment.
• For laboratory positions, potential exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Variable work hours to accommodate schedules

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values

• Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*.

Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Compensation and Benefits The salary range estimated for this position based in Virginia is $75,700.00–$101,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A 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 paid time off (PTO), 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 in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards