What are the responsibilities and job description for the Quality Specialist position at LFB USA?
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
- 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
- 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