Specialist QA Manufacturing Oversight

Specialist QA I Manufacturing Oversight

Location:

Boca Raton, FL

Job Summary: The QA Specialist I - Manufacturing Oversight performs manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include real‑time batch record review, review of manufacturing documentation, and resolution of issues on the manufacturing floor.

• Possess an understanding of Quality Systems (e.g., Deviations, Corrective and Preventive Action reports (CAPAs), Change Controls, and Out of Specifications (OOSs)).
• Perform Quality Assurance review and approval of Event notifications.
• Possess understanding of cGMP and regulatory compliance, including 21 CFR Parts 11, 210, 211 and 600.
• Perform oversight and inspections of active production areas to resolve problems and ensure compliance with SOPs and policies.
• Review and release plasma pools to manufacturing.
• Review all manufacturing support documentation (logbooks, log sheets, charts etc.).
• Perform review and release of raw materials in LIMS/SAP.
• Perform audits of nitrogen receipt process.
• Assist with quarantining and release of critical systems, equipment, and controlled environments.
• Assist in other oversight activities, as needed.
• Coordinate and perform any additional activities or projects assigned by QA Management.
• Experience with LIMS and SAP is preferred.
• Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers).
• Rotate amongst QA Specialists to provide 24/7 manufacturing oversight coverage. Required to work 12‑hour shifts (07:00 AM to 07:00 PM or 07:00 PM to 07:00 AM). Must be available to support coverage on either shift.

Experience Requirements: 1–3 years in the pharmaceutical or biotechnology industry (or related industry).

Education Requirements: Bachelor’s Degree preferred; can be offset by experience.

• 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 in the first year
• Tuition assistance after the first year

ADMA Biologics uses E‑Verify to confirm the employment eligibility of all new hires. ADMA Biologics is an Equal Opportunity Employer.