Specialist QA I - Manufacturing Oversight Job at Planet Group, Boca Raton, FL

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  • Planet Group
  • Boca Raton, FL

Job Description


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.

Qualifications
ESSENTIALS OF THE JOB:
  • Possess an 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 Event notifications.
  • Possess and 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.)
  • 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.
  • 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 is preferred.

Education Requirements: Bachelor's Degree preferred but can be offset by experience. 

Experience Requirements: 1-3 years’ experience in pharmaceutical or biotechnology industry or other related industry preferred

Job Tags

Permanent employment, Shift work,

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