Specialist QA II Manufacturing Oversight

Role Summary

The QA Specialist II - Manufacturing Oversight will perform 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. Based in Boca Raton, FL.

Responsibilities

• Possess and 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 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

• Required: 3-5 years' experience in pharmaceutical or biotechnology industry or other related industry.
• Preferred: Experience with LIMS and SAP.
• Preferred: Familiarity with Quality Systems and cGMP initiatives; ability to ensure QA records and reports, HR policies, and EH&S procedures are completed in a timely manner.

Skills

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

Education

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