Center Quality Specialist

Join to apply for the Center Quality Specialist role at LFB USA

• Perform donor record file review
• Perform equipment quality control review (daily, weekly, monthly, semi‑annual and annual)
• Review medical reports and communications
• Review equipment incidents
• Verify and release sample shipments
• Inspect and release incoming supplies
• Initiate deviation reports as needed
• Perform weekly employee observations
• Assist the Manager of Quality Assurance with compliance of state and federal regulations, FDA‑approved SOP Manual, CLIA, cGMP, OSHA and internal procedures
• Review documentation of unsuitable test results and disposition of associated units

• Conduct root cause analysis for deviations and customer complaints related to donor safety and product quality
• Review equipment records and donor system information to approve out‑of‑service equipment for use
• Review and approve deferred donor reinstatement activities
• Review look‑back information
• Review waste shipments
• Initiate investigations and report supplies that have not met quality specifications before use
• Review medical incident reports and documentation

• High school diploma, GED or equivalent required. Associate’s degree preferred or a minimum of 3–6 months of 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, organizational skills and follow‑up
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and technical manuals
• Ability to interpret technical instructions in mathematical or diagram form and deal with 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 hours at a time
• Ability to lift, tug, pull up to fifty pounds

• Entry level

• Full‑time

• Quality Assurance

Palm Beach Gardens, FL $82,000.00‑$ (2 weeks ago)