Job Information
Fagron Sterile Services Manufacturing Quality Assurance Specialist in Wichita, Kansas
This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13550142
The MQA Specialist reports to the Manufacturing Quality Manager and works closely with Operations personnel and Environmental Monitoring Technicians to complete on-the-floor audits and training of behavior and technique.
Key Responsibilities
- Ability to identify and report on QA events related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
- Responsible for timely and accurate process review of batch records and QA checks within the manufacturing process.
- Provides review of production specific Deviations / Investigations, CAPAs, Change Controls
- Assist in generating procedures related to Manufacturing QA functions / activities
- Observe and identify conformance to defined procedures and batch specific steps within the aseptic areas
- Periodically review records to verify that quality standards for each drug product is met
- Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
- Prepares weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities
- Responsible for maintaining all testing equipment in compliance, calibration, and certification.
- Assists in developing policies and procedures related to QA
- Promptly communicates with Operations regarding complaints, product issues/variances.
- Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation
- Enforce compliance with QA processes, Equipment Qualification, and Computer System Validation principles. Support all regulatory and customer quality audits.
- Gather, organize & analyze data to develop solutions & alternative methods of proceeding compliantly
- Assist CAPA teams, and other project teams, in the development of action plans and implementation schedules, and the verification of completed actions.
- Conduct periodic internal reviews or audits to ensure that compliance procedures are followed.
- Conduct and report the findings of internal investigations of compliance issues.