Associate Scientist - Dry Lab - QC Reviewer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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 shift for this role is Monday - Friday from 8AM-5PM EST

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.

Become an Associate Scientist - QC Reviewer at Thermo Fisher Scientific Inc. and help advance our goal of empowering customers to enhance worldwide health, cleanliness, and safety. This role offers a rare opportunity to verify the premium quality of laboratory data and reports, contributing significantly to our projects.

What You'll Do:
• Review the accuracy of laboratory data.

• Evaluate chromatography data and associated notebooks in accordance with Standard Operating Procedures (SOPs).
• Evaluate data to ensure compliance with analytical methods, client criteria, and Good Laboratory Practices (GLP).
Requirements
• Proven experience in reviewing laboratory data and documentation.
• Outstanding attention to detail and capacity to review chromatography data.
• Strong understanding of SOPs and GLP requirements. Communicates with laboratory staff to proactively address the quality of laboratory documentation.
• Ability to work collaboratively in a team environment to successfully implement quality control measures.

Knowledge, Skills and Abilities:

• Knowledge of applicable regulatory authority, compendia and ICH guidelines

• Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use

• Ability to utilize Microsoft Excel and Word to perform tasks

• Ability to independently optimize analytical methods

• Good written and oral communication skills

• Time management and project management skills

• Problem solving and troubleshooting abilities

• Ability to work in a collaborative work environment with a team

Education and Experience
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years) or equivalent combination
of education, training, & experience.

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.

Working Conditions and Environment:
• Work is performed in an office and/or a laboratory and/or a clinical environment with exposure to electrical equipment.
• Occasionally drives to site or client locations, occasionally travels within the United States.
• Exposure to biological fluids with potential exposure to infectious organisms. Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Requirements:
• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both h