QA Auditor I - Labs

Thermo Fisher Scientific • Middleton, WI

1d • Onsite

About The Position

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 innovations. Discover Impactful Work: Conducts internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies and applies company policies and procedures to resolve routine issues. Delivers billable quality services for clients and projects. This role assures the quality of lab data and reports.

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 1-2 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.
• Familiar with applicable GxP and appropriate regional regulations
• Detailed understanding of SOPs and WPDs
• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
• Strong attention to detail
• Able to work independently or in a team environment
• Strong problem-solving abilities
• Strong interpersonal and time management skills
• Computer experience and ability to learn and become proficient with appropriate software
• 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

Responsibilities

• Audits laboratory data for compliance with methods and standard operating procedures and report findings
• Audit sample result tables and analytical reports for completeness and accurate representation of the data and findings
• Serves as support to operational departments on audit or quality assurance subject matter
• Assists in the preparation of audit findings and/or other related information

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level