Quality Specialist - Plasma Center

LFB; Florida; On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

Health insurance?

Paid time off?

Job summary

LFB in Florida is seeking a Quality Assurance professional to perform donor record and equipment quality control reviews, as well as review medical reports and incidents. You will verify sample shipments and the release of incoming supplies, while initiating deviation reports as needed.

Under the QA Manager, you will ensure compliance with CLIA, cGMP, FDA SOPs, OSHA and internal procedures, and participate in root cause analyses for deviations and complaints affecting donor safety and product

Qualifications

• High school diploma, GED or equivalent required.
• Associate's degree preferred; 3–6 months quality or plasma industry experience required.

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 SOP Manual, CLIA, cGMP, 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

Education

Associate's degree preferred

3–6 months quality/plasma 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