Plasma - Quality Assurance Specialist

<p>Essential Job Responsibilities and Duties<span>  </span><br />• Perform donor record file review<br />• Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual<br />• Review medical reports and communication<br />• Perform reviews of equipment incidents<br />• Verification and release of sample shipment<br />• Responsible for the inspection and release of incoming supplies<br />• Initiate deviation reports as needed<br />• Perform Weekly employee observations<br />• 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<br />• Reviews the documentation of unsuitable test results and the disposition of the associated units<br /><br />In the absence of the Manager of Center Quality Assurance:<br />• 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<br />• Review of equipment records and donor system information, if applicable, to approve out of service equipment for use<br />• Review and approval of deferred donor reinstatement activities<br />• Review lookback information<br />• Waste shipment review<br />• Initiates investigations and reports any supplies that have not met quality specifications and requirements before use<br />• Review medical incident reports and documentation<br />Qualifications<br />• High school diploma, GED or equivalent required.<span>  </span>Associates degree preferred or a minimum of (3) three to (6) six months quality or plasma industry experience required.<br /><br />Requirements<br />• Strong verbal and written communication skills<br />• Must have above average problem-solving and decision-making abilities<br />• Proficiency with computers<br />• Must have explicit attention to detail<br />• Must have excellent analytical skills, organization skills, and follow-up<br />• Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals<br />• Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables<br /><br />Physical Requirements<br />• Use hands to handle or feel objects, tools, or controls; reach with hands and arms; and talk or hear<br />• Frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee<br />• Manual dexterity to perform all phases of donor plasmapheresis<br />• Ability to make and analyze a physical assessment of heart, lung sounds, signs of drug use, etc.<br />• Ability to stand for extended periods of time for up to four (4) hours at a time<br />• Ability to lift, tug, pull up to fifty (50) pounds<br /> </p>