Full Job Description
We are seeking an experienced Quality Control Analyst to perform and review analytical testing supporting raw-material, in-process, release, stability, validation, and investigation activities. Core duties and responsibilities include the following:
Job Duties:
• Perform and document routine and complex analytical testing in accordance with approved methods, specifications, SOPs, protocols, and schedules.
• Review raw data, calculations, chromatograms, audit trails, worksheets, and results for accuracy, completeness, and compliance.
• Support or lead method transfer, verification, validation, troubleshooting, and lifecycle improvements for assigned methods.
• Execute raw-material, in-process, release, stability, cleaning, or investigation testing as assigned.
• Lead or support laboratory investigations, OOS/OOT assessments, deviations, CAPAs, and change controls.
• Operate, maintain, calibrate, and troubleshoot analytical instruments and laboratory systems; coordinate service when needed.
• Prepare and revise methods, SOPs, protocols, reports, specifications, forms, and training materials.
• Train and mentor analysts and provide technical guidance while preserving independent review requirements.
• Plan work against manufacturing and project priorities and communicate constraints or risks early.
• Support inspections, customer audits, data requests, and continuous-improvement initiatives.
Requirements
• Bachelor's degree in chemistry, biochemistry, pharmaceutical science, or a related field.
• 5-7 years of QC analytical experience in pharmaceutical, biotechnology, API, or another GMP-regulated laboratory.
• Strong knowledge of cGMP, GDP, data integrity, OOS/OOT, deviations, CAPA, and controlled-document practices.
• Hands-on experience with relevant chromatographic and analytical instrumentation, data systems, and method troubleshooting.
• Strong documentation, technical writing, prioritization, and cross-functional communication skills.
Benefits
• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee's family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
• Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
• Disability insurance 50% standard employer paid.
• 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
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities