Specialist QA Manufacturing Oversight

Job Title

Specialist QA I Manufacturing Oversight

The QA Specialist I - Manufacturing Oversight performs manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to, real‑time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.

Competencies:

Ability to follow cGMP procedures with great attention to detail.

• 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 an understanding of cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600.
• Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies.
• Review and release of 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).
• Rotation 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.

1–3 years’ experience in the pharmaceutical or biotechnology industry or other related industry preferred.

Bachelor's Degree preferred but can be offset by experience.

• 401K 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 (within the first year).
• Tuition Assistance (after the first year).
• Easily accessible to Tri‑Rail. Free shuttle to the Boca Tri‑Rail station.

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ADMA Biologics is an Equal Opportunity Employer.