Specialist QA II Manufacturing Oversight

Role Summary

Specialist QA II Manufacturing Oversight in Boca Raton, FL. The QA Specialist II - Manufacturing Oversight will perform manufacturing oversight activities to ensure compliance with policies and procedures, including real-time batch record review and review of manufacturing documentation, and resolution of issues on the manufacturing floor.

Responsibilities

• Possess and understanding of processes such as 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 Deviation Reports.
• 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.
• Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers) and their associated activities, as required.
• Review and release of Plasma pools to manufacturing.
• Review all manufacturing support documentation (logbooks, log sheets, charts, etc.).
• Review and release of raw materials in LIMS/SAP.
• Perform audits of 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.

Qualifications

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

Skills

• Exceptional organizational and communication skills; excellent writing and oral skills.
• Ability to perform real-time review and ensure compliance with QA processes and regulatory requirements.

Additional Requirements

• Experience with LIMS and SAP preferred.