Center Quality Specialist-1
About The Position
The Center Quality Specialist is responsible for ensuring compliance with all state and federal regulations, FDA-approved Standard Operating Procedure Manual, Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), Occupational Safety and Health Administration (OSHA), and internal company procedures. This role involves performing various reviews of donor records, equipment quality control, medical reports, and incidents. The specialist also handles the verification and release of sample shipments and incoming supplies, initiates deviation reports, and conducts employee observations. In the absence of the Manager of Center Quality Assurance, the specialist will conduct root cause analysis for deviations and customer complaints, review equipment and donor system information, approve deferred donor reinstatements, review lookback information, and waste shipments. They will also investigate and report any supplies that do not meet quality specifications.
Requirements
- Strong verbal and written communication skills
- Must have above average problem-solving and decision-making abilities
- Proficiency with computers
- Must have explicit attention to detail
- Must have excellent analytical skills, organization skills, and follow-up
- Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals
- Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
Nice To Haves
- Associates degree preferred
- A minimum of (3) three to (6) six months quality or plasma industry experience required
Responsibilities
- Perform donor record file review
- Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual
- Review medical reports and communication
- Perform reviews of equipment incidents
- Verification and release of sample shipment
- Responsible for the inspection and release of incoming supplies
- Initiate deviation reports as needed
- Perform Weekly employee observations
- Assist the Manager of Quality Assurance with compliance of all state and federal regulations, FDA-approved Standard Operating Procedure Manual, Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), Occupational Safety and Health Administration (OSHA), and internal company procedures
- Reviews the documentation of unsuitable test results and the disposition of the associated units
- In the absence of the Manager of Center Quality Assurance: Conduct root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product
- Review of equipment records and donor system information, if applicable, to approve out of service equipment for use
- Review and approval of deferred donor reinstatement activities
- Review lookback information
- Waste shipment review
- Initiates investigations and reports any supplies that have not met quality specifications and requirements before use
- Review medical incident reports and documentation
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
