Specialist QA II Manufacturing Oversight

Specialist QA II Manufacturing Oversight

ADMA Biologics is a biopharmaceutical company committed to creating superior products for immunodeficient patients. We are seeking a Specialist QA II Manufacturing Oversight to join our Boca Raton, FL team.

The QA Specialist II will perform manufacturing oversight activities to ensure compliance with policies and procedures. Key responsibilities include real‑time batch record review, documentation review, issue resolution, and oversight of production areas.

• Possess understanding of processes such as Quality Systems (e.g., Deviation, CAPA, Change Control, OOS).
• Perform QA review and approval of Deviation Reports.
• Understand cGMP and regulatory compliance (21 CFR 11, 210, 211, 600).
• Oversee production areas to resolve problems and ensure SOP compliance.
• General oversight of Buildings 1 and 2 (including cold rooms/freezers).
• Review and release of plasma pools to manufacturing.
• Review support documentation (logbooks, charts).
• Review and release raw materials in LIMS/SAP.
• Audit nitrogen receipt process.
• Notify and disposition Lookback units.
• Assist with quarantining/release of critical systems, equipment, and controlled environments.
• Write, review, and revise QA SOPs.
• Review SOPs and documents from other departments and provide feedback.
• Assess necessity of Deviations, CAPAs, and Change Controls.
• Assist with training of new employees.
• Coordinate and perform additional activities/projects assigned by QA Management.
• Experience with LIMS and SAP preferred.

• Bachelor's Degree preferred; experience may offset.
• 3‑5 years of experience in pharmaceutical or biotechnology industry or related.

• 401(k) plan with employer match and immediate vesting
• Medical, vision, life, and dental insurance
• Pet insurance
• Company‑paid STD and LTD
• Company‑paid holidays
• 3 weeks Paid Time Off (first year)
• Tuition Assistance (after first year)
• Tri‑Rail free shuttle to Boca Tri‑Rail station
• ADMA Biologics uses E‑Verify to confirm employment eligibility.
• ADMA Biologics is an Equal Opportunity Employer.

Location:

Boca Raton, FL
Seniority level:
Mid‑Senior

Employment type:

Full‑time
Job function:
Quality Assurance