Chemist, Quality Control

CSBio•Menlo Park, CA

7h•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