Center Quality Assurance Specialist

4 weeks ago


Florence, Colorado, United States LFB Full time

Job Summary
We are seeking a highly skilled Center Quality Assurance Specialist to join our team at LFB. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and safety in our plasma donation center.

Key Responsibilities
Perform donor record file review to ensure compliance with regulatory requirements
Conduct equipment quality control reviews to ensure optimal performance and safety
Review medical reports and communication to identify potential quality issues
Investigate equipment incidents and initiate deviation reports as needed
Verify and release sample shipments to ensure quality and safety
Inspect and release incoming supplies to ensure compliance with quality standards
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 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 (4) hours at a time
Ability to lift, tug, pull up to fifty (50) pounds



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