Overview
Quality Assurance Specialist Jobs in Houston, TX at Aequor
Title: Quality Assurance Specialist
Company: Aequor
Location: Houston, TX
Job Title: QA Specialist II
Location: Houston, TX 77047
Duration: 06+ Months
Shift: Sun – Thu (11pm – 8am)
Position Overview:
- 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
Key Accountabilities:
- 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.
Education:
- Bachelor’s degree in Life Science or Engineering
Area of expertise:
- GMP experience in the biologics and pharma industry.
- Working knowledge of equipment/facilities qualifications, GMP and GDP environment
Skills:
- Experience with regulations (US, EU and others)
- Experience in a biopharmaceutical manufacturing environment
- Experience in equipment / facilities / utilities validation activities
- Strong experience in GDP
