Position Title: QA Specialist II – QA Operations

Work Location: Houston, TX 77047

Assignment Duration: 06 months

Work Arrangement: Onsite

Work Schedule: Sunday to Thursday 11pm - 8am

Position Summary:
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.

Key Responsibilities:
• 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.

Qualification & Experience:
• Bachelor Degree – Life Science or Engineering
• English (Written and spoken) – Business Fluent
• GMP experience in the biologics and pharma industry
• Working knowledge of equipment/facilities qualifications, GMP and GDP environment
• Entry Level - 0-4 years
• Experience with regulations (US, EU and other)
• Experience in a biopharmaceutical manufacturing environment
• Experience in equipment / facilities / utilities validation activities
• Strong experience in GDP

Working Conditions & Physical Demands (If Applicable):
• Travel: <10%
• Must follow job safety procedures and comply with safety policies
• Adherence to cGMPs required at all times
• Office Setting environment
• Requires sitting, walking, standing, gowning, fine motor skills

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 40.00/hr.