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Thermo Fisher Scientific · 6 hours ago

QC Scientist II

St Louis, MO

Full-time

Onsite

Entry, Mid Level

2+ years exp

Thermo Fisher Scientific is a leading company in the biopharmaceutical industry, seeking a QC Scientist II to ensure product quality and safety in their laboratories. The role involves conducting complex analytical testing, executing validated test methods, and maintaining compliance with GMP regulations while contributing to continuous improvement initiatives.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

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

Qualification

HPLCGCCGMP regulationsLIMSMethod validationProblem-solvingAttention to detailWritten communicationVerbal communicationTeam collaboration

Required

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

May require flexible scheduling including occasional weekend work