QA Oversight Specialist, Manufacturing (12h Shifts)

BioSpace; Boca Raton (FL); Vor Ort; USD 70.000 - 100.000; Vollzeit

Benefits dieser Stelle

401K with employer match

Medical insurance

Vision insurance

Life Insurance

Dental Insurance

Pet Insurance

Short‑term disability

Long‑term disability

Paid holidays

Paid time off

Tuition assistance

Zusammenfassung

ADMA Biologics is seeking a Specialist QA I Manufacturing Oversight in Boca Raton, FL. The role focuses on QA oversight of manufacturing processes, batch record review, and ensuring compliance with cGMP and company policies to support safe, effective biopharmaceutical production.

Responsibilities include review and approval of event notifications, inspections of production areas, release of plasma pools, and collaboration with QA management on projects and process improvements.

Qualifikationen

• Understanding of Quality Systems including Deviations, CAPAs, Change Controls and OOSs.
• Knowledge of and ability to apply cGMP and regulatory requirements (21 CFR Parts 11, 210, 211, 600).
• Experience with real‑time batch record review and manufacturing documentation in a QA capacity.

Aufgaben

• Perform real‑time manufacturing batch record review and resolution of on‑the‑floor issues.
• Review and approve event notifications and manufacturing documentation.
• Oversee and inspect active production areas to ensure SOP and policy compliance.
• Review and release plasma pools to manufacturing; review raw materials in LIMS/SAP.
• Coordinate audits of nitrogen receipt process and assist in quarantining critical systems.

Kenntnisse

Quality Systems

cGMP knowledge

QA oversight

Documentation review

Ausbildung

Bachelor's Degree

Tools

LIMS

SAP

Jobbeschreibung

ADMA Biologics is seeking a Specialist QA I Manufacturing Oversight in Boca Raton, FL. The role focuses on QA oversight of manufacturing processes, batch record review, and ensuring compliance with cGMP and company policies to support safe, effective biopharmaceutical production.

Responsibilities include review and approval of event notifications, inspections of production areas, release of plasma pools, and collaboration with QA management on projects and process improvements.