QC Scientist II, QC Data Review

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Youll perform sophisticated analyses to ensure product quality and safety in our laboratories. As a QC Scientist II youll conduct complex analytical testing to support GMP manufacturing of biopharmaceutical products from early-stage clinical development through commercial release. Youll work with analytical instruments and technologies while making a meaningful impact on patient health through precise quality control testing.

Working with cross-functional teams youll execute validated test methods participate in method development and validation activities investigate out-of-specification results and maintain detailed documentation of analyses. Youll 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 Bachelors 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.