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Chemist, Quality Control

CSBioMenlo Park, CA
Onsite

About The Position

The QC Chemist is responsible for performing chemical and analytical testing to support raw material, in-process, release, and stability programs in a GMP-regulated environment. This role executes compendial, validated, and approved internal test methods; ensures laboratory activities are documented in accordance with internal quality standards, cGMP requirements, and applicable regulatory expectations; and supports method qualification, laboratory investigations, equipment maintenance, and continuous improvement of QC laboratory systems.

Requirements

  • Bachelor’s degree in Chemistry or a related scientific discipline.
  • Typically 2+ years of relevant experience, ideally in a GMP pharmaceutical, biotech, or contract testing laboratory environment.
  • Hands-on experience with analytical instrumentation including HPLC/UPLC, GC, Karl Fischer, and elemental analysis.
  • Experience writing or contributing to reports, SOPs, protocols, and technical documents.
  • Proficiency with Microsoft Word, Excel, and PowerPoint.

Nice To Haves

  • Working knowledge of cGMP and GLP documentation practices preferred.
  • Knowledge of chemical synthesis processes and API manufacturing is preferred but not required.

Responsibilities

  • Perform QC testing in support of raw material, in-process, finished product, API, and stability testing using approved methods, specifications, and procedures.
  • Operate analytical instrumentation, including HPLC/UPLC, GC, Karl Fischer, and elemental analysis equipment, and perform routine data review to ensure results are accurate, complete, and compliant.
  • Complete test records, laboratory notebooks, logbooks, worksheets, and controlled forms accurately and contemporaneously in compliance with internal quality standards, cGMP requirements, and applicable regulations.
  • Review analytical data for completeness, accuracy, and adherence to approved methods and good documentation practices.
  • Assist in method qualification and related activities, including feasibility testing, protocol execution, data compilation, and preparation or revision of qualification and validation reports as required.
  • Support transfer, implementation, and continuous improvement of analytical methods used in the QC laboratory.
  • Prepare, review, and revise QC-related SOPs, specifications, test methods, forms, and other controlled documents as needed to support compliant laboratory operations.
  • Perform in-house calibration, routine verification, troubleshooting, and preventive maintenance of laboratory instruments and equipment according to approved procedures and schedules.
  • Assist with laboratory events, deviations, out-of-specification or out-of-trend results, and other laboratory investigations to support timely resolution and appropriate documentation.
  • Maintain a clean, organized, and inspection-ready laboratory environment and perform other related duties as required by the company.

Benefits

  • Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 90% for Employee and 75% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
  • 401k 10% 1:1 match
  • PTO policy. 10 days PTO
  • Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
  • Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
  • Disability insurance 50% standard employer paid.
  • Carpool, clean air vehicle, and cell phone reimbursement
  • Employee rewards and recognition program
  • Company organized social events
  • Quarterly sponsored team building activities

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Based on current job postings on Teal, the average Chemist salary in the US is approximately $86,000 per year, with a typical range of $42,000 to $169,000.
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