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Thermo Fisher Scientific · 15 hours ago

QC Scientist II, QC Data Review

St Louis, MO

Full-time

Onsite

Entry, Mid Level

2+ years exp

Thermo Fisher Scientific is a global leader in serving science, and they are seeking a QC Scientist II to ensure product quality and safety in their laboratories. In this role, you will conduct complex analytical testing to support GMP manufacturing of biopharmaceutical products and contribute to continuous improvement initiatives while adhering to cGMP requirements.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

Responsibilities

Perform sophisticated analyses to ensure product quality and safety in our laboratories

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

Qualification

HPLCGCCGMP regulationsLIMSMethod validationAseptic techniquesAnalytical skillsMicrosoft OfficeProblem-solvingCommunication skills

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