Center Quality Specialist-1

LFB Biopharmaceuticals; Anniston (AL); On-site; USD 42,000 - 64,000; Full time

Job summary

LFB Biopharmaceuticals in Anniston, Alabama is seeking a Quality Assurance associate responsible for donor record reviews, equipment QC reviews, and reviewing medical reports to ensure compliance with CLIA, FDA cGMP, OSHA and internal SOPs.

The role requires attention to detail, strong problem-solving, computer proficiency, and the ability to interpret safety rules and complex procedures. Join a team dedicated to quality and patient safety in a plasma-derived product environment.

Qualifications

• Strong verbal and written communication skills.
• Above-average problem-solving and decision-making abilities.
• Proficiency with computers.
• Explicit attention to detail.
• Excellent analytical, organizational and follow-up skills.
• Ability to read and interpret safety rules, operating and maintenance instructions, and procedures.
• Ability to interpret complex technical instructions.

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 SOPs, CLIA, cGMP, OSHA, and internal procedures.
• Review documentation of unsuitable test results and disposition of units.
• Conduct root cause analysis for deviations and customer complaints related to safety and product quality.
• Review equipment records and donor system information to approve out-of-service equipment.
• Review and approve deferred donor reinstatement activities.
• Review lookback information and waste shipment reviews.
• Initiate investigations and report supplies not meeting quality specs.
• Review medical incident reports and documentation.

Skills

Strong verbal communication skills

Strong written communication skills

Attention to detail

Problem-solving and decision-making

Proficiency with computers

Analytical and organizational skills

Education

High school diploma or GED

Associates degree preferred

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

Today, LFB is among the leading European bio-pharmaceutical companies providing mainly hospital-based healthcare professionals with plasma-derived or recombinant medicinal products in three major therapeutic areas: immunology, haemostasis, and intensive care. Life of patients is our purpose! Let's Work together in a climate of sharing, mutual exchange, trust and transparency. We are committed to hiring a diverse and talented workforce. AA/M/F/D/V. This organization participates in E-Verify.