Center Quality Specialist

LFB•Fort Pierce, FL

14d•Onsite

About The Position

The Center Quality Specialist is responsible for ensuring the quality and safety of the donor and the product. This role involves performing various reviews and inspections, assisting with compliance, and conducting investigations as needed. In the absence of the Manager of Center Quality Assurance, this role will take on additional responsibilities related to root cause analysis and approval of various activities.

Requirements

High school diploma, GED or equivalent required.
Associates degree preferred or a minimum of (3) three to (6) six months quality or plasma industry experience required.
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
Plasma industry experience

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)