Drug Product Quality Assurance Specialist (Biotech)

Location: Thousand Oaks, California, United States

Annual salary: $104,287.35–$141,094.65

Company

hirify.global is a biotechnology company developing and manufacturing medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Provide quality oversight for aseptic drug product manufacturing, inspection, utilities, and validation activities.
• Manage and review quality records, including deviations, CAPAs, change controls, document revisions, and effectiveness checks.
• Lead or support root cause analyses, risk assessments, investigations, and compliance evaluations.
• Review and approve controlled documents such as SOPs, protocols, and reports.
• Partner with Manufacturing, Facilities & Engineering, Quality Control, Supply Chain, and Automation teams.
• Support audits, regulatory inspections, continuous improvement projects, and digital quality solutions.

Requirements

• Doctorate degree; or master’s degree with 2 years of quality experience; or bachelor’s degree with 4 years; or associate’s degree with 8 years; or high school diploma/GED with 10 years.
• Bachelor’s degree in science preferred.
• 5+ years of aseptic processing experience in QA or manufacturing preferred.
• Experience with deviation investigations, root cause analysis, CAPA, change control, risk management, and quality management systems.
• Knowledge of contamination control, environmental monitoring, and utility monitoring in GMP manufacturing environments.
• Strong analytical, communication, project management, and cross-functional leadership skills.

Culture & Benefits

• Collaborative, innovative, science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.