The QA Specialist Level II-Quality Operations supports manufacturing operations and all support groups related to manufacturing execution. 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.

Contract: W2 only; 6 months plus extension over 1 year plus

Location: Houston, Tx; fully onsite

Required Skills:

• Experience with regulations (US, EU and other)
• Experience in a biopharmaceutical manufacturing environment
• Experience in equipment / facilities / utilities validation activities
• Strong experience in GDP

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.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.