Specialist Quality Assurance (GxP)

Location: On site in Juncos, Puerto Rico, United States

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines for serious diseases.

What you will do

• Lead and make quality decisions for major deviation investigations, including designation, documentation, resolution, and closure.
• Manage multiple concurrent deviations and drive timely, compliant outcomes through deviation meetings and cross-functional collaboration.
• Provide floor support through process observation and personnel interviews across shifts.
• Review and approve production records, laboratory results, deviations, procedure updates, and related cGMP documentation.
• Assess quality, compliance, supply, and patient safety risks; communicate and escalate issues to senior management when appropriate.
• Defend deviation investigations during internal audits, regulatory inspections, and leadership reviews, while supporting continuous improvement.

Requirements

• Doctorate degree; or a master’s degree and 2 years of Quality Assurance experience; or a bachelor’s degree and 4 years of Quality Assurance experience; or an associate’s degree and 8 years of Quality Assurance experience; or a high school diploma/GED and 10 years of Quality Assurance experience.
• Experience with Quality Systems, deviations, CAPA, and CAPA Effectiveness Verification in a regulated GxP environment.
• Experience leading root cause investigations, facilitating RCA discussions, and driving cross-functional alignment.
• Ability to evaluate compliance issues, perform trend analysis, identify systemic quality risks, and produce evidence-based documentation compliant with ALCOA+ and Good Documentation Practices.
• Experience supporting drug product operations, manufacturing floor activities, regulatory inspections, and audits.
• Flexibility to support variable schedules and cross-time-zone interactions.

Nice to have

• Academic degree in Microbiology, Engineering, Chemistry, or a related scientific field.
• Experience using digital tools, automation, and AI-enabled tools to improve investigation effectiveness.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, and disability insurance for eligible employees and dependents.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time off, annual site shutdown, work-life balance support, and career development opportunities.