QA Auditor I

Thermo Fisher Scientific • Middleton, WI

12d • Onsite

About The Position

This is a fully onsite role based at our BioAnalytical Laboratory in Middleton, WI. 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. The working schedule for this role is Monday - Friday from 8AM-5PM. 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. Location/Division Specific Information Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic authorities. 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. A Day in the Life • Audits laboratory data for compliance with methods and standard operating procedures and report findings • Audits sample result tables and analytical reports for completeness and accurate representation of the data and report findings • Serves as a resource to operational departments on audit or quality assurance subject matter • Assists in the preparation of audit findings and/or other related information Keys to Success Education and Experience Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associates' degree and relevant experience is acceptable in lieu of Bachelor's degree Previous QA or lab 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.

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associates' degree and relevant experience is acceptable in lieu of Bachelor's degree
• Previous QA or lab experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years’)
• Familiar with applicable GxP and appropriate regional regulations
• Thorough working knowledge 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 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.

Responsibilities

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

Benefits

• We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
• Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees