Sign upLog in

Manufacturing Quality Assurance Specialist

Fagron Sterile Services

Wichita, KS

Apply
JOB DETAILS
SKILLS
Asepsis, Calendar Management, Calibration, Change Control, Cleanroom, Computer Systems, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Current Good Manufacturing Practice (cGMP), Data Analysis, Drug Products, Environmental Monitoring, Equipment Maintenance/Repair, Establish Priorities, FDA (Food and Drug Administration), Federal Laws and Regulations, Housekeeping/Cleaning, Internal Audit, Maintain Compliance, Manufacturing, Manufacturing Management, Manufacturing Operations, Manufacturing/Industrial Processes, Metrics, Operational Communications, Policy Development, Procedure Development, Quality Assurance, Quality Assurance Methodology, Quality Management, Quality Metrics, Reconciliation, System Validation, Test Equipment, Time Management, Trend Analysis
LOCATION
Wichita, KS
POSTED
30+ days ago
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.

About the Company

F

Fagron Sterile Services