Sr Associate QA I - PQA

Location: On-site in Holly Springs, North Carolina, United States; PQA staff work on-site and transition to shift schedules including late afternoons and nights.

Company

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

What you will do

• Provide real-time quality oversight for bulk drug substance manufacturing and new product introduction.
• Support facility commissioning, qualification, analytical equipment validation, and quality document review.
• Ensure manufacturing, testing, storage, and distribution comply with cGMP, GDP, regulations, and internal quality requirements.
• Review and close deviations, investigations, CAPAs, change controls, validations, procedures, and records.
• Guide on-floor analytical testing, assess quality-impacting changes, and escalate quality, compliance, supply, and safety risks.
• Support audits and regulatory inspections, project management activities, and continuous improvement initiatives.

Requirements

• High school diploma/GED plus 4 years of relevant experience, or an associate degree plus 2 years, or a bachelor's degree plus 6 months; a master's degree also qualifies.
• Experience in quality, manufacturing, or another regulated environment.
• Strong cGMP and GDP knowledge, with experience in biotechnology or pharmaceutical manufacturing preferred.
• Understanding of upstream or downstream biotechnology production operations and GMP testing laboratories.
• Experience with deviations and electronic systems such as EBR/MES, DeltaV, and electronic quality systems.
• Strong organizational, communication, teamwork, independent working, and task-management skills.

Culture & Benefits

• Collaborative, innovative, and science-based working environment.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible staff and dependents.
• Retirement and savings plan with company contributions, stock-based long-term incentives, and an annual bonus program.
• Paid time off, work-life balance support, and career development opportunities.
• Shift-based support for continuous 24/7 manufacturing operations.

Hiring process

• Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
• Sponsorship for this role is not guaranteed.