at Fagron Sterile Services in Wichita, Kansas, United States
Job Description
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.
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 in 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 to maintain 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.
