LFB USA ยท 1 day ago
Center Quality Specialist
Fort Pierce, FL
Full-time
Onsite
New Grad, Entry Level
0+ years expLFB USA is seeking a Center Quality Specialist to ensure the quality and compliance of donor records and equipment in the plasma industry. The role involves reviewing documentation, conducting quality control assessments, and assisting with regulatory compliance to maintain high safety and quality standards.
Biotechnology
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
Qualification
Required
High school diploma, GED or equivalent required
Minimum of (3) three to (6) six months quality or plasma industry experience required
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
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
Preferred
Associates degree preferred
Company
LFB USA
LFB USA is a biotechnology company in the Boston, Massachusetts.
51-200 employees
H1B Sponsorship
LFB USA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
William Gavin
Chief Operating Officer
Company data provided by crunchbase