Specialist QA I Manufacturing Oversight

Role Summary

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.

Responsibilities

• Possess an understanding of Quality Systems (e.g., Deviations, Corrective and Preventive Action (CAPA) reports, 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.

Qualifications

• Preferred: 1-3 years’ experience in pharmaceutical or biotechnology industry or other related industry.
• Preferred: Bachelor's Degree or equivalent experience.

Skills

• Ability to follow cGMPs and procedures with great attention to detail.

Education

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