QA Oversight Specialist – Manufacturing (12-Hour Shifts)

ADMA Biologics; Boca Raton (FL); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

401K with match

Medical, Vision & Dental insurance

Pet Insurance

STD/LTD

Holidays

Paid Time Off 3 weeks

Tuition Assistance

Shuttle to Tri-Rail

Job summary

ADMA Biologics is seeking a Specialist QA I Manufacturing Oversight in Boca Raton, FL. The role focuses on real-time batch review, documentation oversight, and ensuring compliance with cGMP and FDA requirements.

The Specialist will perform QA review and release activities, oversee production areas, and coordinate inspections. 1–3 years in pharma/biotech and a Bachelor’s degree are preferred; LIMS/SAP experience is a plus. This is a 12-hour shift role with 24/7 coverage rotation.

Qualifications

• Experience in pharmaceutical or biotechnology industry (1–3 years preferred).
• Bachelor's degree preferred but can be offset by experience.
• Strong understanding of FDA regulations and quality systems is required.
• Experience with LIMS and SAP is preferred.

Responsibilities

• Perform QA review and approval of event notifications.
• Oversee and inspect active production areas for GMP and SOP compliance.
• Review and release plasma pools and manufacturing documentation.
• Review and release of raw materials in LIMS/SAP.
• Coordinate with QA management on inspections and CAPAs.
• Provide 24/7 manufacturing oversight coverage on 12-hour shifts.

Skills

Quality systems

cGMP knowledge

Documentation

Education

Bachelor's degree preferred

Tools

LIMS

SAP

Job description

ADMA Biologics is seeking a Specialist QA I Manufacturing Oversight in Boca Raton, FL. The role focuses on real-time batch review, documentation oversight, and ensuring compliance with cGMP and FDA requirements.

The Specialist will perform QA review and release activities, oversee production areas, and coordinate inspections. 1–3 years in pharma/biotech and a Bachelor’s degree are preferred; LIMS/SAP experience is a plus. This is a 12-hour shift role with 24/7 coverage rotation.