Job Details

Essential Job Responsibilities and Duties

* 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

Qualifications

* 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.

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

Physical Requirements

* 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