Quality Specialist - Plasma Center

LFB•Spokane Valley, WA

About The Position

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.

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

Nice To Haves

Associates degree preferred

Responsibilities

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
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