QC Senior Chemist

Work Schedule

Environmental Conditions

Job Description

Position Summary

Join Thermo Fisher Scientifics Quality Control team as a Senior QC Chemist. You will ensure cGMP and regulatory compliance while delivering analytical solutions through expertise in biologics chemistry method qualification/validation and timely project completion. Responsibilities include overseeing lab activities leading investigations and promoting quality culture and compliance across the site.

Responsibilities

• Support new equipment qualification lab systems and chemistry lab setup.

• Perform transfer/verification/validation of analytical methods.

• Prepare technical documentation (protocols SOPs reports).

• Conduct analysis of raw materials intermediates finished products and stability samples under cGMP.

• Oversee sampling testing and release processes for process aids and packaging materials.

• Ensure timely chemistry testing (HPLC GC particle counting etc.) to support production.

• Manage daily lab operations in compliance with GMP and company standards.

• Update processes in response to new pharmacopoeia/regulatory changes.

• Lead lab investigations/deviations and ensure timely closure per Quality System.

• Review analytical data for accuracy and compliance.

• Perform equipment maintenance and calibration.

• Troubleshoot analytical methods and equipment issues.

• Manage QC chemical reference standard and consumable inventory.

• Train and maintain training records for team members.

• Stay updated on international regulations (GMP GLP ICH pharmacopoeias).

• Act as SME during audits/inspections.

• Support internal audits inspections and continuous improvement.

• Promote Quality Culture and 4i values.

• Adhere to HSE GMP and 5S standards.

• Support shift work as needed.

Minimum Requirements/Qualifications

Education:

• Bachelors degree in Chemistry Biochemistry or Life Sciences.

Experience:

• Minimum 5 years in pharmaceutical/biotech Quality Control.

• Knowledge of FDA EMA HSA PIC/S and ICH regulations.

• Strong cGMP knowledge and QC chemistry techniques (HPLC UPLC CE).

• Experience with method transfer and validation.

• Excellent communication skills in English.

• Ability to work cross-functionally and under regulatory scrutiny.

• Audit and inspection readiness experience.