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Center Quality Specialist

2 months ago

Florence, South Carolina, United States LFB Full time
{"title": "Center Quality Specialist", "content": "Job Summary

We are seeking a highly skilled Center Quality Specialist to join our team at LFB. In this role, you will be responsible for ensuring the highest quality standards in our plasma donation center.

Key Responsibilities
  • Perform donor record file review and ensure accuracy and completeness.
  • Conduct equipment quality control reviews on a daily, weekly, monthly, semi-annual, and annual basis.
  • Review medical reports and communication to ensure compliance with regulations.
  • Perform reviews of equipment incidents and initiate deviation reports as needed.
  • Verify and release sample shipments and inspect incoming supplies.
  • 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.
  • Review documentation of unsuitable test results and the disposition of associated units.
Requirements
  • High school diploma, GED or equivalent required. Associate's degree preferred or a minimum of 3-6 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.
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 hours at a time.
  • Ability to lift, tug, pull up to fifty pounds.
", "lang_code": "en-US"}