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Center Quality Specialist

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Assessfirst

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Location:
United States , Fort Pierce

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Essential Job Responsibilities and Duties and Qualifications

Job Responsibility:

  • 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

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
  • Use hands to handle or feel objects, tools, or controls
  • reach with hands and arms
  • and talk or hear
  • Frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee
  • Manual dexterity to perform all phases of donor plasmapheresis
  • Ability to make and analyze a physical assessment of heart, lung sounds, signs of drug use, etc.
  • Ability to stand for extended periods of time for up to four (4) hours at a time
  • Ability to lift, tug, pull up to fifty (50) pounds

Additional Information:

Job Posted:
December 21, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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