QC PDS Quality Operations Analyst

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION

As a QC PDS Quality Operations Analyst, you will join our collaborative PDS team, working cross-functionally in a GMP/GLP-regulated environment and contributing to the development and delivery of advanced products and technologies that help address global challenges in healthcare and environmental protection.

The primary focus of this role will be the review and verification of analytical activities and documentation generated by the QC PDS laboratory, ensuring accuracy, completeness, data integrity, and compliance with applicable procedures and GMP/GLP requirements. This will include the review of analytical testing and documentation related to product release, stability studies, analytical method validation and transfer activities, and Active Pharmaceutical Ingredients (APIs), using standard analytical techniques and instrumentation such as HPLC, UV-Vis, FT-IR, and Pharmacopoeial methods.

While the position is predominantly focused on quality review and oversight, you will also receive appropriate laboratory training to maintain the capability to operate as a QC PDS Laboratory Analyst. When required, you may provide hands-on support to routine laboratory activities and analytical testing.

We offer an environment that values performance, quality, and innovation, providing the resources and opportunities to develop your expertise and grow your career while contributing to our mission of enabling our customers to make the world healthier, cleaner and safer.

REQUIREMENTS

• Minimum 2 years of experience in a GMP/GLP-regulated analytical laboratory environment, with knowledge of analytical techniques such as HPLC, GC, FT-IR, and UV-Vis spectrophotometry.
• Bachelor’s or Master’s degree in Chemistry, Biology, Biochemistry, Chemical Engineering, or a related scientific discipline.
• Strong working knowledge of GMP/GLP requirements, quality systems, and data integrity principles.
• Experience in the review of analytical data, laboratory documentation, and test results, ensuring accuracy, completeness, and compliance with applicable procedures and regulatory requirements.
• Proficiency with Laboratory Information Management Systems (LIMS) and/or other laboratory data management systems.
• Knowledge of analytical method development, validation, and transfer activities.
• Demonstrated ability to maintain and review accurate laboratory documentation and records in accordance with ALCOA/ALCOA+ principles.
• Proficiency in Microsoft Office Suite, particularly Excel.
• Strong written and verbal communication skills in English, with the ability to communicate effectively in a cross-functional environment.
• Strong attention to detail, organizational skills, and ability to manage priorities in a quality-driven and regulated environment.
• Flexibility to provide occasional laboratory support, including evenings or weekends, when required.