Quality Control Chemist

4 weeks ago


Decatur, United States Rising Pharmaceuticals Full time
Job DescriptionJob Description

Title: Quality Control Chemist / QC Chemist

Role: Full Time / Direct Hire

Location: Decatur, IL, USA

JOB DESCRIPTION:

Position Title: Quality Control Chemist Department: Quality Control

Reports To: Supervisor of Quality Control Work Location: Decatur, Illinois

Position Summary:

  • Perform the sampling of raw materials, chemical and physical analysis of raw material, bulk formulations, finished products, stability samples, and any non-routine samples.

Essential Duties & Responsibilities:

  • Sampling and testing of raw materials per approved procedure.

  • Physical and chemical testing of bulk and (pre-fill, finished product, and stability) product.

  • Upkeep of laboratory notebook.

  • Maintaining the work area in an orderly manner.

  • Maintaining Lab inventory like list of standards, chemical, reagent etc.

  • Recording daily activity like PH verification, balance verification, temperature and humidity monitoring of lab stability chambers, freezer, refrigerator etc.

  • Experience in the operation of handling QC major instruments like HPLC, GC, UV, IR, Auto titrator, etc.

  • Perform Finished product/in-process/cleaning validation and raw material analysis independently.

  • Complete testing within specified timeframes and document results accurately

  • Coordinate with vendor for instrument PM, calibration and qualification activity.

  • Provide necessary support.

  • Maintain and monitor lab GLP activity like instrument calibration/qualification schedule, Preparation of instrument operating procedure, coordinate with metrology team and vendor for scheduling period calibration/qualification activity etc.

  • Performs calibration of lab instruments whenever possible.

  • Cleaning of laboratory glassware.

  • Responsible for writing SOP for instrument operation/ calibration etc.

  • Provide necessary support for OOS/OOT investigation.

  • Preparation of stability schedule, Protocol, and report per ICH requirements.

  • Adhere to regulatory guidelines (e.g., FDA, ICH, GMP) and company quality standards during testing and documentation.

  • Ensure adherence to Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP) during testing procedure.

Must Haves:

  • Bachelor’s degree in science field (Chemistry preferred) required, a minimum of 2 years’ experience.

  • Must be full-time on-site, working in the lab.

  • This is a permanent role, therefore, must be open to relocation and/or living in Decatur, IL Monday – Friday.

  • Familiar with liquid, sterile injectables a plus.



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