Specialist QA II Manufacturing Oversight

Location: Boca Raton, Florida, United States; on-site 12-hour shifts from 07:00 AM to 07:00 PM or 07:00 PM to 07:00 AM.

Company

hirify.global is a biopharmaceutical company manufacturing, marketing, and developing specialty plasma-derived products for patients at risk of infectious diseases.

What you will do

• Perform real-time manufacturing batch record review and review manufacturing support documentation, including logs, charts, and logbooks.
• Provide QA oversight and inspections in active production areas, Buildings 1 and 2, cold rooms, freezers, and controlled environments.
• Review and release plasma pools and raw materials in LIMS and SAP.
• Review and approve deviation reports and support investigations involving CAPAs, change controls, and out-of-specification events.
• Audit nitrogen receipt processes, manage lookback unit notifications and dispositions, and support quarantine and release of critical systems and equipment.
• Write, review, and revise QA SOPs, provide feedback on departmental documents, and assist with employee training and assigned QA projects.

Requirements

• Bachelor's degree preferred; equivalent experience may offset the education requirement.
• 3–5 years of experience in the pharmaceutical, biotechnology, or related industry.
• Understanding of cGMP and FDA regulations, including 21 CFR Parts 11, 210, 211, and 600.
• Strong organizational, written, and oral communication skills.
• Availability for 12-hour shifts supporting 24/7 manufacturing oversight.
• Experience with LIMS and SAP is preferred.

Culture & Benefits

• 401(k) plan with employer match and immediate vesting.
• Medical, vision, life, dental, and pet insurance.
• Company-paid short- and long-term disability coverage and holidays.
• Three weeks of paid time off during the first year.
• Tuition assistance after the first year.
• Access to Tri-Rail with a free shuttle to the Boca Tri-Rail station.