What are the responsibilities and job description for the QA Specialist position at Fagron Sterile Services US (FSS)?
This job was posted by https://www.kansasworks.com : For more
information, please see: https://www.kansasworks.com/jobs/13549088
The Quality Assurance Specialist is an intermediate level professional
position responsible for quality assurance activities associated with
cGMP manufacturing, documentation, and product disposition. Ensures that
proper controls are followed and maintained during the manufacturing,
processing, packaging, and warehousing of compounded products.
**Key Responsibilities**
processes.
others as assigned.
information, please see: https://www.kansasworks.com/jobs/13549088
The Quality Assurance Specialist is an intermediate level professional
position responsible for quality assurance activities associated with
cGMP manufacturing, documentation, and product disposition. Ensures that
proper controls are followed and maintained during the manufacturing,
processing, packaging, and warehousing of compounded products.
**Key Responsibilities**
- Execute and develop proficiency in all Level 1, Level 2, and Level 3
- Level 1:
- Manufacturing / Packaging Line Clearances
- Product Label Review and Approval
- Product Label Reconciliation
- EMS Data Review
- Logbook Review and reconciliation
- Level 2:
- Batch Record Issuance
- Batch Record Review and Approval
- Incoming Material Review and Approval
- Form and Logbook Issuance
- Review and Approval of Testing Data
- Review and Approval of Event Reports and Associated Corrective
- Level 3:
- Disposition and Release of Incoming Materials
- Disposition and Release of Finished Product
- Document Control Activities
- Review and Approval of Change Controls and controlled document
- Special Projects as assigned
- Review and Approval of Moderate Risk Deviations
- Support execution of product Batch Records and associated
processes.
- Ensure day-to-day compliance to all requirements established for
- Assist with problem identification and resolution efforts for
- Assist with internal, corporate, 3rd party and federal/state
- Provide contributing information on measures of local quality system
others as assigned.
- Ensure cGMP documentation associated with work activities meets
- Maintain assigned training standard operating procedures.
- Perform other related duties as assigned.