Center Quality Specialist-1

Lfb USA; Anniston (AL); On-site; USD 42,000 - 65,000; Full time

Job summary

Lfb USA in Anniston, AL is seeking a Quality Assurance Associate to perform donor record file reviews, equipment quality control reviews, and review medical reports and communications.

You will assist with compliance to FDA/CLIA/cGMP/OSHA standards, investigate deviations, review equipment records, and participate in root-cause analysis. Strong detail orientation and computer proficiency are required.

Qualifications

• High school diploma or GED required; associates degree preferred.
• 3–6 months quality or plasma industry experience is a plus.
• Strong communication and attention to detail are essential.

Responsibilities

• 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.
• 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.

Skills

Verbal communication

Written communication

Attention to detail

Problem solving

Proficiency with computers

Analytical skills

Organizational skills

Follow-up

Education

High school diploma or GED

Associates degree preferred or 3-6 months quality or plasma industry experience

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