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 Today, LFB is among the leading European bio-pharmaceutical companies providing mainly hospital-based healthcare professionals with plasma-derived or recombinant medicinal products in three major therapeutic areas: immunology, haemostasis, and intensive care. Life of patients is our purpose! Let's Work together in a climate of sharing, mutual exchange, trust and transparency. We are committed to hiring a diverse and talented workforce. AA/M/F/D/V. This organization participates in E-Verify.

Center Quality Specialist-1.

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