Website Revive Business Solutions
Revive Business Solutions
Company : Revive Business Solutions
Pos ition: QA Specialist
Duration: 6 + months (Possible to extension)
Location: Houston, TX
Sunday to Thursday, 11 PM – 8 AM
Job Description:
The QA Specialist Level II-Quality Operations represents the QA department ensuring that quality requirements are met. Support manufacturing operations
and all support groups related to manufacturing execution. Supports investigations using problem solving tools. Supports corrective actions and
change controls as needed. Review and approve GMP master documents and executed GMP documents from QC, manufacturing, material management,
and any other department that supports lot production. Other duties include tracking quality records, QA on the floor execution, and overall cGMP
compliance.
Verify the company's compliance with ISO/GMP quality system requirements and other regulatory guidance as appropriate.
provide oversight for compliance of CAPA and minor deviations.
Perform QA walkthroughs and work closely with manufacturing and support groups to resolve any issues identified during the walkthroughs.
Support activities that involves QA presence on the floor.
Review Master Batch Records (MBR) and supporting documents to support batch disposition. Perform review/release of Buffer/ media as needed.
Perform other duties as assigned.
GMP experience in the biologics and pharma industry. Working knowledge of equipment/facilities qualifications, GMP and GDP environment
Entry Level – 0-4 years
Skills
Experience in a biopharmaceutical manufacturing environment
Experience in equipment / facilities / utilities validation activities
Strong experience in GDP