The Manufacturing Quality Assurance (MQA) Specialist supports GMP manufacturing processes, ensuring compliance, process integrity, and inspection readiness. They work directly on the cleanroom floor, providing real-time guidance, reviewing batch records, logbooks, deviations, SOPs, and supporting facility walkthroughs and client interactions. Responsibilities include deviation triage, facility response, alarm management, and process improvement initiatives. The role involves collaborating across departments, supporting deviation resolution, and ensuring GMP standards are maintained.
Knowledge and skills vary by experience level, requiring GMP industry experience, understanding of manufacturing processes, and strong communication abilities. Shift work is 12 hours on a rotating 2-2-3 schedule. The role offers a salary range of $55,000-$86,900 and encourages diverse applicants.