QC Scientist II

Thermo Fisher Scientific•Saint Louis, MO

1d•Onsite

About The Position

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 ana lytical processes while adhering to cGMP requirements and safety standards. We have 2 positions available. A Day in the Life: Perform testing on In-Process, DS release, DP release, DS stability, DP Stability, and various other non-routine samples, ensuring timely delivery for projects Participate in analytical method validation/transfer, method establishment/qualification routine and stability analysis. Conduct GMP testing in an analytical laboratory environment using Separation Techniques, BioAssay Analysis and Compendia test methods (i.e. Reverse Phase, SEC, Titer concentration, iCE, pH, Osmolarity, Residual DNA, Appearance) Compiles data for documentation of test procedures, prepares reports. Ensures all testing processes, monitoring, and departmental documentation meet SOPs and cGMP regulatory standards. Participate in the development of new concepts, techniques, and standards. Involved with assisting in the preparation of CoAs. Recognize and report out-of-specification/ out-of-trend results to laboratory management; recommend solutions. Perform all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines Partake in laboratory activities, including safety inspections and client audits in a timely matter.

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
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
Must be able to pass a comprehensive background check, which includes a drug screening
Must be legally authorized to work in the United States now or in the future, without sponsorship.

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

Perform testing on In-Process, DS release, DP release, DS stability, DP Stability, and various other non-routine samples, ensuring timely delivery for projects
Participate in analytical method validation/transfer, method establishment/qualification routine and stability analysis.
Conduct GMP testing in an analytical laboratory environment using Separation Techniques, BioAssay Analysis and Compendia test methods (i.e. Reverse Phase, SEC, Titer concentration, iCE, pH, Osmolarity, Residual DNA, Appearance)
Compiles data for documentation of test procedures, prepares reports.
Ensures all testing processes, monitoring, and departmental documentation meet SOPs and cGMP regulatory standards.
Participate in the development of new concepts, techniques, and standards.
Involved with assisting in the preparation of CoAs.
Recognize and report out-of-specification/ out-of-trend results to laboratory management; recommend solutions.
Perform all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines
Partake in laboratory activities, including safety inspections and client audits in a timely matter.