QA Release Technician

Job Task(s)

This position requires the following requirements for employment at Stallergenes Greer and includes but not limited to:

• Ensure that all SOPs and master batch records, paper or electronic, follow cGMP requirementas and are in accord with business needs.
• Manage the release of commercial lots, review batch records after execution. Participate in the lot disposition decisions and complete lot disposition. Identify issues and support correction process.
• Support audits and inspections by ensuring all documents are readily available and organized.
• Verify that all products have met all testing requirements and manufacturing specifications prior to releasing the batch records. Identify issues and support correction process.
• Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
• Provides support for submissions to CBER for release by completing and reviewing the required documentation. Review documentation meets good documentation procedures and calculations are correct.
• Manages and/or assists in the disposal of discarded product discovered during inspection process according to procedure.
• Collation and organization of batch records for submission to DCO.
• Seek continuous improvement opportunities to enhance quality systems
• Enters work order completion information into JD Edwards computer applications and enters recorded values in electronic systems.
• Manage KPIs for Quality Assurance Release.
• Assist in developing and implementing an electronic batch record system.
• Good working knowledge of current regulations including FDA, ICH, USP guidance.