Center Quality Specialist

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