Specialist QA II Manufacturing Oversight

Role Summary

Specialist QA II Manufacturing Oversight role based in Boca Raton, FL. Responsible for conducting manufacturing oversight activities to ensure compliance with policies and procedures, including real-time batch record review and review of manufacturing documentation.

Responsibilities

• Possess and understand processes such as Quality Systems (Deviations, CAPAs, Change Controls, OOSs).
• Perform Quality Assurance review and approval of Deviation Reports.
• Understand cGMP and regulatory compliance per 21 CFR Parts 11, 210, 211, and 600.
• Perform oversight and inspections of active production areas to resolve problems and ensure SOP/policy compliance.
• Oversee Buildings 1 and 2 (including cold rooms/freezers) and related activities as required.
• Review and release Plasma pools to manufacturing.
• Review all manufacturing support documentation (logbooks, log sheets, charts, etc.).
• Review and release of raw materials in LIMS/SAP.
• Audit Nitrogen receipt processes.
• Notify and disposition associated Lookback units.
• Assist with quarantining and release of critical systems, equipment, and controlled environments.
• Write, review, and revise QA SOPs; provide feedback on documents from other departments.
• Collaborate with other departments to assess if Deviations, CAPAs, and Change Controls are required.
• Assist with training of new employees.
• Coordinate and perform additional activities or projects assigned by QA Management.
• Experience with LIMS and SAP preferred.

Qualifications

• Education: Bachelor‚Äôs Degree preferred but can be offset by experience.
• Experience: 3-5 years in pharmaceutical or biotechnology industry or related field.

Skills

• Exceptional organizational and communication skills; excellent writing and oral communication is required.