QA Auditor I

Thermo Fisher Scientific • Richmond, VA

4d • Onsite

About The Position

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. As a Quality Assurance Auditor I and play a crucial role in ensuring compliance and excellence in our clinical auditing processes.

Requirements

• 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.

Nice To Haves

• Vaccine, Immunology, or Molecular experience is a plus.
• 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.

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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree