This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13389086

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.

Fagron Sterile Services

Latest Jobs

Manufacturing Quality Assurance Specialist