QA Auditor I
Thermo Fisher Scientific
Summary
As a Quality Assurance Auditor I, you will play a crucial role in ensuring compliance and excellence in our clinical auditing processes.
Job description
What You'll Do
- 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
Education and Experience
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). 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.
Knowledge, Skills and Abilities
- 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
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 comparable to 1 year
- Introductory knowledge of applicable GxP and appropriate regional regulations
- Working knowledge of SOPs
- Strong oral and written communication skills
- 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
- 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
- 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
Benefits
- Medical, Dental & Vision
- Health Incentive Programs
- Employee Assistance Program
- Family Support Programs
- Commuter Benefits
- Tuition Reimbursement
- Paid Time Off
- Paid Holidays
- Paid Parental Leave
- Accident Insurance
- Life Insurance
- Short-term Disability
- Long-term Disability
- 401(k) Retirement Savings Plan
- Employee Stock Purchase Plan
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.