Center Quality Specialist

lfb; Florence (SC); On-site; USD 42,000 - 66,000; Full time

Job summary

LFB is seeking a QA-oriented candidate to support donor plasmapheresis processes and ensure adherence to CLIA, cGMP, OSHA, and internal SOPs. The role focuses on reviewing records, equipment quality checks, and incident investigations.

Responsibilities include documentation, release of samples, and assisting the QA Manager with regulatory compliance. Excellent attention to detail and communication skills are required in a fast-paced plasma environment.

Qualifications

• High school diploma or GED required; associates degree preferred.
• 3–6 months quality or plasma industry experience recommended.
• Must have strong reading, writing and documentation skills.

Responsibilities

• Review donor records and equipment quality control on a routine schedule.
• Review medical reports, incidents and documentation for compliance.
• Verify and release samples and inspect incoming supplies.
• Initiate deviation reports and assist QA Manager with regulatory compliance.
• Perform weekly employee observations and support root cause analyses when needed.

Skills

Verbal and written communication

Problem solving

Detail oriented

Analytical skills

Computer proficiency

Education

High school diploma or GED

Associates degree preferred

Quality/plasma experience (3–6 months)

Tools

Computers

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