QA Auditor I at Thermo Fisher Scientific in Richmond, VA

Summary: Thermo Fisher Scientific is a leading company in the healthcare industry, dedicated to improving patient health through scientific innovation. As a QA Auditor I, you will play a crucial role in ensuring compliance and excellence in clinical auditing processes.

Responsibilities:
- Conduct a variety of routine client, internal or GxP audits
- Assist or may conduct non-complex process audits
- Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, facility audits, process improvement)
- Serve as a resource to operational departments on audit or quality assurance subject matter
- Assist in the preparation of audit findings and/or other related information

Required Qualifications:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associate degree and relevant experience is acceptable in lieu of bachelor's degree
- Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year)
- Introductory knowledge of applicable GxP and appropriate regional regulations
- Working knowledge of SOPs
- Strong oral and written communication skills (including appropriate use of medical and scientific terminology)
- Good attention to detail
- Able to work independently or in a team environment
- Good problem-solving abilities
- Good organizational and time management skills
- Basic computer skills and ability to learn and become proficient with appropriate software
- Proven flexibility and adaptability
- Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
- 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

Preferred Qualifications:
- Vaccine, Immunology, or Molecular experience is a plus

Required Skills: GxP regulations, SOPs, Clinical auditing, Quality assurance audits, Laboratory experience, Vaccine experience, Immunology, Molecular biology, Medical and scientific terminology

Benefits: A comprehensive Total Rewards package including:, 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, 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