Quality Control Analyst III

TL;DR

Quality Control Analyst III: Perform complex pharmaceutical quality control testing and data evaluation (HPLC, ELISA) with an accent on cGMP/GLP compliance, OOS investigations, and stability program execution. Focus on troubleshooting equipment, validating test methods, leading root cause analyses and CAPAs, and maintaining accurate regulated documentation.

Location: Camarillo, 93012

Salary: $120,200–$125,000

Company

hirify.global provides staffing for quality and laboratory roles in regulated environments.

What you will do

• Run complex testing and evaluate results, including HPLC and ELISA, and assess data trends.
• Troubleshoot equipment issues and communicate resolutions to management.
• Support test method validations and execute, author, and review SOPs, reports, protocols, investigations, change controls, and data summaries.
• Investigate OOS events with thorough root cause analyses, assess potential product impact, and implement appropriate CAPAs.
• Coordinate testing with outside labs and raw materials, maintain detailed records, and enter data into data management systems with tracking and trending.
• Lead departmental projects and the stability program, including management of test points and investigations of out-of-specification or aberrant stability results.

Requirements

• Bachelor’s degree in chemistry (or related field) with 5+ years of related experience, or Master’s degree with 3+ years, or PhD with 1+ years.
• Experience working in a cGMP or GLP pharmaceutical industry environment.
• Ability to work flexible hours, including nights and weekends, as needed (overtime eligible).
• Strong understanding of regulatory and compliance guidelines for the pharmaceutical industry.
• Experience performing root cause analyses and CAPA implementation for quality events.

Culture & Benefits

• Major medical, dental, vision, and 401k benefits for temporary assignments lasting 13 weeks or longer, plus statutory sick pay where required.
• Reasonable accommodations available during the employment process.
• Equal opportunity employer with participation in E-Verify in certain required locations.