QA SPECIALIST II – QA OPERATIONS @ SAILOTECH
Sailotech is seeking a dedicated QA Specialist II – Quality Operations for a long-term contract position in Houston, TX. This role is vital in supporting manufacturing operations to ensure strict adherence to cGMP, ISO, and other relevant regulatory standards. As a key representative of the Quality Assurance function on the shop floor, the successful candidate will work closely with manufacturing and support teams to drive excellence and maintain high-quality standards throughout the production process.
The responsibilities include providing QA oversight for Corrective and Preventive Actions (CAPAs) and minor deviations, performing regular walkthroughs to resolve issues in real-time, and reviewing critical documentation such as Master Batch Records (MBRs). You will also be involved in batch disposition activities, including the review and release of buffer and media. This position requires a professional with a strong pharmaceutical background and hands-on experience in Quality Assurance operations within a GMP manufacturing environment to ensure overall compliance and quality excellence.
The responsibilities include providing QA oversight for Corrective and Preventive Actions (CAPAs) and minor deviations, performing regular walkthroughs to resolve issues in real-time, and reviewing critical documentation such as Master Batch Records (MBRs). You will also be involved in batch disposition activities, including the review and release of buffer and media. This position requires a professional with a strong pharmaceutical background and hands-on experience in Quality Assurance operations within a GMP manufacturing environment to ensure overall compliance and quality excellence.
Key Requirements
Strong pharmaceutical industry background required.
Hands-on experience in QA Operations within a manufacturing environment.
In-depth knowledge of cGMP, ISO, and regulatory requirements.
Experience providing QA oversight for CAPAs and minor deviations.
Ability to perform QA walkthroughs and collaborate with manufacturing groups.
Proficiency in reviewing and approving Master Batch Records (MBRs).
Experience with executed GMP documentation and batch disposition.
Strong understanding of media and buffer review and release processes.
Ability to track quality records and ensure total compliance.
Excellent communication skills for partnering with support teams.