Manufacturing Quality Assurance Specialist

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.