Plasma - Quality Assurance 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