QA Specialist I

Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting, Office Job Description This is a hybrid role based at our GMP 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. Location: Flexible Hybrid; Middleton, WI Available Shifts: Full-Time; 1st Shift, Monday - Friday, 8PM - 4PM CT The Quality Assurance Specialist provides expertise in one or more specialized areas of the Quality Management System (QMS) and plays a critical role in ensuring compliance with GMP and regulatory requirements. This position serves as a key Quality Assurance representative for customer and regulatory audits, partnering with internal teams to host inspections conducted by client organizations and regulatory agencies. The role is essential in maintaining audit readiness, demonstrating the organization's commitment to quality, and fostering customer confidence through successful audit execution. The Quality Assurance Specialist also participates in cross-functional meetings, provides quality guidance, and serves as a QA contact for company-contracted services.

The PPD GMP Middleton site hosts approximately 100 client audits per year. This role serves as a key QA resource for client audits Provide support to nearly every audit through a combination of pre-audit preparation, day of audit logistics and hosting, and post-audit follow-up Stage records as outlined in audit agenda Be present in audits to answer questions and fulfill document requests Monitor responses to audit findings to ensure they are provided to client by defined due date Provide support during regulatory inspections Knowledge, Skills, and Abilities: Thorough knowledge of applicable GxP regulations and regional regulatory requirements. Firm knowledge of the clinical trial process. Demonstrated experience supporting and hosting customer and regulatory audits in a GMP environment. Strong customer-facing communication, presentation, and relationship management skills. Ability to coordinate cross-functional teams to ensure audit readiness and successful inspection outcomes. Good knowledge of SOPs and WPDs. Excellent oral and written communication skills. Strong attention to detail and organizational skills. Effective problem-solving and time management skills. Ability to work independently and collaboratively in a fast-paced environment. Strong computer skills and ability to quickly learn quality systems and business applications. Proven flexibility and adaptability. Valid driver's license and ability to qualify for and maintain a corporate credit card for business travel.

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 of 15 to 40 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. Exposure to fluctuating and/or extreme temperatures on rare occasions. Our Mission is to enable our customers to make the world healthier, cleaner