QA Specialist II (Nights 12 hour Rotating Shift) (GMP)

Location: Durham, North Carolina, United States; onsite work on the cleanroom floor, including nights on a 12-hour rotating shift

Company

hirify.global is a GMP contract manufacturing organization supporting biopharmaceutical manufacturing operations.

What you will do

• Provide real-time Manufacturing Quality Assurance guidance on process requirements, product safety, identity, strength, purity, and quality, as well as risk.
• Review and approve executed batch records and logbooks.
• Guide and generate deviation triage records and support resolution of client comments.
• Perform facility walkthroughs and respond to events that may compromise the clean environment.
• Review SOPs and technical documents for accuracy and provide feedback.
• Support alarm response, bulk-fill label reconciliation, inspection readiness, team initiatives, and coaching or mentoring.

Requirements

• Approximately 4–6 years of appropriate experience, or an associate or bachelor’s degree strongly preferred.
• Experience in GMP, a regulated industry, or a laboratory environment.
• Ability to work effectively across departments and communicate with all organizational levels.
• Ability to represent Quality in interdepartmental meetings and understand manufacturing processes.
• Knowledge of technical documents and ability to review written procedures for accuracy.
• Ability to become a qualified trainer and track and trend department metrics.

Culture & Benefits

• Full-time employment supporting a rapidly expanding GMP manufacturing site.
• Collaborative work with Manufacturing and cross-functional teams.
• Opportunities to coach, mentor, and contribute to site inspection readiness.
• Equal opportunity and affirmative action workplace committed to workforce diversity.