QC Scientist II

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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. How will you make an impact? You'll perform sophisticated analyses to ensure product quality and safety in our laboratories. As a QC Scientist II, you'll conduct complex analytical testing to support GMP manufacturing of biopharmaceutical products, from early-stage clinical development through commercial release. You'll work with analytical instruments and technologies while making a meaningful impact on patient health through precise quality control testing. Working with cross-functional teams, you'll execute validated test methods, participate in method development and validation activities, investigate out-of-specification results, and maintain detailed documentation of analyses. You'll contribute to continuous improvement initiatives and help establish robust analytical processes while adhering to cGMP requirements and safety standards. How will you get there? Advanced degree with no prior experience, or Bachelor's degree with 2 years of experience in a GMP regulated laboratory environment performing analytical testing Preferred Fields of Study: Chemistry, Biology, Biochemistry, or related scientific field Expertise in analytical techniques such as HPLC, GC, CE, ELISA, PCR, and other bioanalytical methods Proficient in aseptic techniques and environmental monitoring procedures Strong knowledge of cGMP regulations and quality control requirements Experience with laboratory information management systems (LIMS) and quality management systems Excellent documentation practices and attention to detail Strong problem-solving and analytical skills Ability to work both independently and collaboratively Proficiency with Microsoft Office applications Strong written and verbal communication skills Ability to lift up to 30 pounds and stand for extended periods Willingness to wear required PPE including lab coat, safety glasses, and gloves May require flexible scheduling including occasional weekend work Experience with method validation and transfer activities preferred Knowledge of data integrity requirements and good documentation practices Demonstrated ability to investigate out-of-specification results and author technical reports