QA Auditor III

Thermo Fisher Scientific; Richmond (VA); On-site; USD 80,000 - 120,000; Full time

Job summary

Thermo Fisher Scientific in Richmond, VA is seeking a Quality Assurance Auditor III to join our BIOA Laboratory onsite. You will lead diverse client, internal, and GxP audits, ensure compliance with global regulatory standards, and prepare audit reports for management and clients.

Requires a Bachelor's degree or equivalent and 5+ years QA experience, strong communication, and root-cause analysis; ability to travel. Onsite role in Richmond; must be authorized to work in the US.

Qualifications

• Detailed knowledge of GxP and regional guidelines.
• Experience leading client, internal or GxP audits.
• Excellent oral and written communication skills.
• Strong risk assessment and root cause analysis abilities.
• Ability to multi-task and prioritize demands.
• Valid driver's license and ability to travel.

Responsibilities

• Lead client, internal or GxP audits and inspections as requested.
• Lead site, facility, vendor and sub-contractor audits.
• Provide GxP consultation and support to project teams.
• Lead process audits and participate as co-auditor in complex audits.
• Perform other QA audits or activities (e.g., database and study report audits).
• Serve as resource to operational departments on audit matters.
• Prepare and present audit findings at meetings.
• Mentor and guide junior auditors.

Skills

GxP knowledge

Audit leadership

Communication skills

Problem solving

Root cause analysis

Negotiation

Multi-tasking

Driver's license

Education

Bachelor's degree or equivalent

Relevant formal qualification

Job description

Work Schedule

First Shift (Days)

Environmental Conditions

Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Position: QA Auditor III

Location: Richmond, VA

Department: Quality Assurance

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.

Join Us as a Quality Assurance Auditor III - Make an Impact at the Forefront of Innovation

The Quality Assurance Auditor III leads complex and/or multi-department internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. This role identifies issues impacting quality and regulatory compliance, determines the root cause of non-conformance, and develops strategies to address these issues. The Quality Assurance Auditor III may perform technical document reviews and other GxP activities in support of project work or company processes. Additionally, the Quality Assurance Auditor III provides finished audit reports to management, plans and delivers billable quality services for clients and projects, and may serve as the client contact.

What You'll Do

• Conduct and/or lead a variety of client, internal or GxP audits and regulatory inspections as requested by senior management
• Lead 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)
• Contacted by others to serve as a 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
• Provide mentorship and guidance to junior auditors

Education & Experience 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 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.

Knowledge, Skills, Abilities

• Detailed 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

Working Conditions and Environment

• Work is performed in an office/ laboratory and/or a clinical environment.
• 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.

he working environment/requirements for this role

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

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.

Accessibility/Disability Access

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 pay range estimated for this position Clinical Auditing Specialist III based in Virginia is –.

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