Specialist QA II Manufacturing Oversight

Job Title

Specialist QA II Manufacturing Oversight

The QA Specialist II – Manufacturing Oversight will perform manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include real‑time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.

• Possess an understanding of processes such as Quality Systems (e.g., Deviations, CAPAs, Change Controls, OOSs).
• Perform quality assurance review and approval of Deviation Reports.
• Understand 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 ensure compliance with SOPs and policies.
• Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers) and their associated activities as required.
• 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 the nitrogen receipt process.
• Perform notification and disposition of associated lookback units.
• Assist with quarantining and release of critical systems, equipment, and controlled environments.
• Write, review, and revise QA SOPs.
• Review SOPs and documents from other departments and provide feedback as necessary.
• Work with other departments to assess if deviations, CAPAs, and change controls are required.
• Assist with training of new employees.
• Coordinate and perform any additional activities or projects assigned by QA management.
• Experience with LIMS and SAP preferred.

Education
:
Bachelor’s Degree preferred but experience may be considered.

Experience
: 3–5 years in the pharmaceutical or biotechnology industry or related.

Communications
:
Excellent writing and oral communication skills.

• 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 (within the first year)
• Tuition assistance (after the first year)
• Free shuttle to the Boca Tri‑Rail station

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ADMA Biologics is an equal‑opportunity employer.