QA Auditor I - Labs

Thermo Fisher Scientific • Middleton, WI

1d

About The Position

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 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. This role assures the quality in the qualification and ongoing calibration and maintenance of equipment, software, and facilities to support laboratory operations. A day in the Life: Audits instrument calibration, maintenance, and qualification documentation for compliance with change control plans and standard operating procedures. 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 Keys to Success: Education Bachelor’s degree or equivalent and relevant formal academic / vocational qualification Experience 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. Knowledge, Skills, Abilities 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 Work Environment Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: 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.

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’)
• 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
• 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.
• This role assures the quality in the qualification and ongoing calibration and maintenance of equipment, software, and facilities to support laboratory operations.
• Audits instrument calibration, maintenance, and qualification documentation for compliance with change control plans and standard operating procedures.
• 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