This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
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
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