QC Scientist II

Thermo Fisher Scientific•Saint Louis, MO

17h

About The Position

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: 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.

Requirements

Advanced degree with no prior experience, or Bachelor's degree with 2 years of experience in a GMP regulated laboratory environment performing analytical testing.
Expertise in analytical techniques such as HPLC, GC, CE, ELISA, PCR, and other bioanalytical methods
Experience performing release and stability testing
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
Must be legally authorized to work in the United States now or in the future, without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening

Nice To Haves

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

Responsibilities

Conduct complex analytical testing to support GMP manufacturing of biopharmaceutical products, from early-stage clinical development through commercial release.
Work with analytical instruments and technologies while making a meaningful impact on patient health through precise quality control testing.
Execute validated test methods
Participate in method development and validation activities
Investigate out-of-specification results
Maintain detailed documentation of analyses
Contribute to continuous improvement initiatives
Help establish robust analytical processes while adhering to cGMP requirements and safety standards.