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Job Title: Senior Quality Control Chemist
Role Overview
We are seeking an analytical and detail-oriented Senior Quality Control Chemist to join our laboratory operations team. In this role, you will be responsible for conducting advanced analytical testing on incoming raw materials, in-process components, final products, and stability samples. This position requires hands-on mastery of complex chromatography and wet chemistry assays alongside an understanding of method development and validation protocols. The ideal candidate is a disciplined professional who applies a strict risk-management framework to data reviews, instrument calibration, and out-of-specification investigations within a regulated manufacturing environment.
Key Responsibilities
Advanced Analytical Testing & Chromatography
• Instrumental Analysis: Perform routine and complex testing using HPLC, GC, UPLC, UV/Visible spectrophotometers, and Total Organic Carbon (TOC) analyzers.
• Assay Execution: Conduct wet chemistry, raw material sampling, and specialized analytical chemistry assays with minimal training.
• Method Management: Perform and assist with quality control method qualifications, cross-laboratory transfers, full validations, and original method development.
• Validation Studies: Lead or support comprehensive equipment cleaning validation studies to prevent product cross-contamination.
Laboratory Governance & Equipment Care
• Calibration Oversight: Serve as the primary driver for laboratory equipment maintenance, routine calibrations, and multi-instrument system checks.
• Data Review: Review analytical QC data, compile trend reports, and provide technical summaries to management to ensure manufacturing accuracy.
• Audit Readiness: Maintain a pristine, compliant workspace and prepare the physical laboratory environment for external regulatory audits.
• Sample Logistics: Manage internal sample receipts, coordinate outside laboratory testing protocols, log results, and track global closures.
Investigation & Compliance Support
• Root-Cause Analysis: Assist QC Management in tracking and completing Out-of-Specification (OOS), deviation, and Corrective and Preventive Action (CAPA) investigations.
• Regulatory Rigor: Ensure all testing, documentation, and data tracking fully comply with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).
Qualifications & Requirements
• Education: Bachelor's degree in Chemistry, Biochemistry, or a closely related scientific field.
• Experience:
oMinimum of 3-5 years of hands-on experience within a pharmaceutical industry environment (or an equivalent combination of advanced education and experience).
oCore experience handling high-volume raw material sampling and stability tracking.
• Technical Skills:
oProven proficiency with chromatography software and hardware (HPLC/GC/UPLC).
oFamiliarity with fundamental laboratory tools: balances, pipettes, pH meters, and IR/UV systems.
• Soft Skills: Strong organizational aptitude, meticulous record-keeping habits, and the communication skills required to present data trends to operational management. Equal Opportunity Employer / Disabled / Protected Veterans
The Know Your Rights poster is available here:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf
The pay transparency policy is available here:
https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf
For temporary assignments lasting 13 weeks or longer, AllSTEM Connections is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.
We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.
AllSTEM Connections participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf
We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Additional Skills
(none specified)
AllSTEM Representative Contact Info
Account Executive:
Nichols
Branch Phone:
(909) 244-1777
Location:
Ontario, CA