Job Description

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.
Qualifications
ESSENTIALS OF THE JOB:

• 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 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.
• 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. Assist in other oversight activities, as needed
• Coordinate and perform any additional activities or projects assigned by QA Management.
• Experience with LIMS and SAP preferred.

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

• 
  3-5 years' experience in pharmaceutical or biotechnology industry or other related industry.
  

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