Quality Specialist - Plasma Center
LFB
Summary
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.
Job description
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
Requirements
- High school diploma, GED or equivalent required
- Associates degree preferred
- Minimum of 3 to 6 months quality or plasma industry experience required
- Strong verbal and written communication skills
- Above average problem-solving and decision-making abilities
- Proficiency with computers
- Explicit attention to detail
- 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
- Ability to lift, tug, pull up to fifty (50) pounds
Company overview
LFB (Laboratoire Français du Fractionnement et des Biotechnologies) is a leading French biopharmaceutical group specializing in the development, manufacturing, and marketing of plasma-derived medicinal products and recombinant proteins. Founded in 1994, the company has established itself as a pillar of French healthcare sovereignty and an internationally recognized force in the plasma industry. LFB focuses on treating serious and often rare diseases across three major therapeutic areas: immunology, haemostasis, and intensive care. As the leading manufacturer of plasma-derived medicinal products in France and the fifth largest worldwide, LFB markets approximately fifteen biomedicinal products in over 30 countries. The company operates five bioproduction sites globally and employs around 3,000 professionals dedicated to fulfilling its public health mission. LFB's commitment to research and development, combined with its innovative rPRO Technology™ platform for recombinant protein production, positions it as a key player in advancing treatments for unmet medical needs in rare disease therapeutics.