QC Scientist II, QC Data Review

ThermoFisher Scientific • Saint Louis, MO • 1d ago

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office, 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.

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

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

Relocation assistance is NOT provided

Must be legally authorized to work in the United States without sponsorship, now or in the future.

Must be able to pass a comprehensive background check, which includes a drug screening.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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