The QA Specialist is responsible for drafting/reviewing/approving validation protocols, SOPs, material specifications, batch records, deviations, out-of-specifications, out-of-tolerances, vendor qualifications, calibration records, line clearances, temperature/humidity/differential pressure reports, and equipment qualification reports. The QA Specialist also provides technical and quality guidance, reviewing, evaluating, and assessing GMP compliances during the manufacturing process and in the Quality Control lab to support the timely release of product and maintain a state of inspection readiness.
• Ensuring that raw materials are correctly processed through the steps of receiving, staging, quarantine, sampling, testing against specifications, and release or rejection per SOP requirements.
• QA Verification of clinical stage and commercial production line clearances and readiness for production.
• Tracking of employee training, sending notices of overdue training, filing and scanning of hard-copy training records.
• Point person for issuance of document control request numbers, equipment identification numbers, and product lot numbers.
• Ensure that appropriate forms are completed correctly upon equipment receipt and that equipment calibration, qualification, and maintenance is performed at the correct intervals for IRISYS GMP equipment.
• Review and approval of calibration certificates, equipment qualification/validation reports, and maintenance records. Responsible for maintaining GMP equipment files.
• Review and approval of raw material and product specifications.
• Review and approval of master and executed production batch records.
• Ensure that all entries made in executed production batch records, logbooks, and forms meet IRISYS GMP documentation requirements as detailed in SOPs.
• Ensure that all production steps were performed as directed by the batch record and SOPs.
• Ensure that deviations that occur during the course of Quality Control activities are elevated to QA and QC management and are written by production staff in a timely manner. QA Associate is responsible for actively participating in the investigation, root cause determination, and corrective/preventive actions as required by management.
• Provide documentation support to lead audit host during client and regulatory audits.
• Perform internal audits of IRISYS quality systems and records for GMP laboratories, manufacturing, facilities and shipping/receiving.
• Coordinate the qualifying of vendors per requirements of internal SOPs. Maintain the schedule qualification schedule.
• Tracking, archiving, distribution of controlled documents.
Job Type: Full-time
• 3-5 years of Quality Control or analytical/bioanalytical chemistry experience in a GMP laboratory in the pharmaceutical industry.
• College Degree required in chemistry, biochemistry, biology, or related science.