Specialist QA Manufacturing Oversight

Specialist QA I Manufacturing Oversight Position Summary

As a QA Specialist I, you will perform manufacturing oversight activities to ensure compliance with policies and procedures. Oversight includes real‑time batch record reviews, review of manufacturing documentation, and resolution of issues on the manufacturing floor.

• Possess an understanding of Quality Systems such as Deviations, CAPAs, Change Controls, and OOSs.
• Perform Quality Assurance review and approval of event notifications.
• Understand cGMP and regulatory compliance (21 CFR Parts 11, 210, 211, and 600).
• Perform oversight and inspections of active production areas to resolve problems and ensure SOP compliance.
• Review and release plasma pools to manufacturing.
• Review all manufacturing support documentation (logbooks, log sheets, charts, etc.).
• Review and release raw materials in LIMS/SAP.
• Perform audits of nitrogen receipt processes.
• Assist with quarantining and release of critical systems, equipment, and controlled environments.
• Assist in other oversight activities, as needed.
• Coordinate and perform any additional projects assigned by QA Management.
• Experience with LIMS and SAP is preferred.
• Oversee Buildings 1 and 2 (including cold rooms/freezers).
• Rotate among QA Specialists to provide 24/7 manufacturing oversight coverage. Work 12‑hour shifts (07:00‑19:00 or 19:00‑07:00), with availability for either shift.

• 1 to 3 years of experience in the pharmaceutical or biotechnology industry (or related field).
• Ability to follow cGMP procedures with great attention to detail.
• Bachelor’s Degree preferred (experience may offset this requirement).
• Preferred experience:
  
  LIMS and SAP knowledge.

• 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.
• Three weeks’ paid time off during the first year.
• Tuition assistance after the first year.
• Accessible to Tri‑Rail; free shuttle to the Boca Tri‑Rail station.

ADMA Biologics uses E-Verify to confirm employment eligibility. ADMA Biologics is an Equal Opportunity Employer.