ESSENTIAL JOB FUNCTIONS:
Reviews SOPs (Standard Operating Procedures) to ensure that the most recently
approved SOP procedures and forms are in the donor center procedure manuals and in
Complies with federal, state, local and company-specific regulations related to quality of
product, employee and donor safety and to the proper performance of day-to-day
Reviews equipment calibration, validation, and maintenance records to ensure they are
performed correctly and on time.
Reviews freezer and refrigerator charts and temperature records for compliance with
Performs QA review of external sample and product shipment releases and shipping
Performs QA review of training records to ensure compliance with SOP, training manual
Performs QA review of deviation reports.
Ensures donor center’s licenses and certificates are in-date and valid.
Reviews donor record files daily, per DCOP instruction.
Reviews of all product destruction records for compliance with SOPS.
Stages plasma units for shipment; requires pulling plasma cases in and out of freezer.
Performs Quality Control Procedures
Performs QA review of reactive donor records, including look-back records for
compliance with SOP.
Reviews Quality Control checks on equipment, reagents, and that records have been
performed, as required and are in acceptable ranges.
Performs audits for self-assessment evaluation, monitor records, and overall compliance
related to the company quality systems.
Attends and assists in all audits and ensures that all audits (internal and external) are
performed, documented, reviewed, and closed.
Assists in maintaining the established quality system under any requirements that affect
the donor center and helps ensure that all operations in the donor center are in
compliance with the Company’s Quality Program.
Assists in, conducts, and evaluates donor center training and orientation programs.
Bachelor’s degree in applicable field of study preferred or equivalent job experience.
Must have a minimum of one (1) year related work experience, preferably in a donor
One (1) year work experience in biologics quality assurance preferred.
Must have legible handwriting.
Must possess knowledge and aptitude to learn various computer software; such as word
processing, spreadsheets, or other related software programs.
Must have adequate communication skills and be able to effectively communicate with
people of all levels.
Must have excellent organizational skills and must be detail-oriented.
Ability to operate computer software, including keyboard, typewriter, and calculator.
Note: A QAT backup may be required by specific regulatory agencies. QAT experience and
background must be approved by Quality Management.
Ability to sit or stand for extended periods for up to four (4) hours at a time.
Ability to tug, lift and pull up to thirty-five (35) pounds.
Ability to bend, stoop or kneel.
Occupational exposure to blood borne pathogens.
Ability to view video display terminal less than 18”away from face for extended periods of
time, up to four (4) hours at a time.
The employee is required to enter an environment with a temperature of -40º for short
periods of time.