Quality Specialist - Plasma Center

LFB Biopharmaceuticals; Florida; On-site; USD 40,000 - 60,000; Full time

Job summary

LFB Biopharmaceuticals is seeking a quality assurance professional in the Town of Florida, NY. The role involves performing various quality control reviews, conducting root cause analysis, and ensuring compliance with federal regulations.

Candidates should have a high school diploma or GED, with experience in the quality or plasma industry preferred. Strong analytical skills and attention to detail are critical. Physical demands include the ability to lift and make physical assessments.

Qualifications

• Minimum of 3 to 6 months quality or plasma industry experience required.

Responsibilities

• Perform donor record file review.
• Perform equipment quality control review.
• Review medical reports and communication.
• Conduct root cause analysis for deviations and customer complaints.
• Review of equipment records and donor system information.

Skills

Strong verbal and written communication skills

Problem-solving and decision-making abilities

Attention to detail

Analytical skills

Organizational skills

Education

High school diploma or GED

Associate's degree preferred

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

Responsibilities 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. Associate’s 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 hours at a time
• Ability to lift, tug, pull up to fifty pounds

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