Center Quality Specialist-1

LFB•Anniston, AL

1d•Onsite

About The Position

The Center Quality Specialist is responsible for ensuring the quality and safety of donor records, equipment, and product. This role involves performing various reviews, quality control checks, and assisting the Manager of Quality Assurance with regulatory compliance. In the absence of the Manager, the Specialist will conduct root cause analyses, review specific documentation, and manage investigations related to quality deviations.

Requirements

Strong verbal and written communication skills
Above average problem-solving and decision-making abilities
Proficiency with computers
Explicit attention to detail
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
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 (in absence of Manager)
Review of equipment records and donor system information, if applicable, to approve out of service equipment for use (in absence of Manager)
Review and approval of deferred donor reinstatement activities (in absence of Manager)
Review lookback information (in absence of Manager)
Waste shipment review (in absence of Manager)
Initiates investigations and reports any supplies that have not met quality specifications and requirements before use (in absence of Manager)
Review medical incident reports and documentation (in absence of Manager)