Associate Quality Assurance Engineer
3 weeks ago
Job Responsibilities & Summary:
Oversee various aspects of ViaCord's document management processes, this includes but not limited to:
Review client records for HCT/Ps that are sent for clinical trial participation, transplant, or research and review of batch records for contract processing.
Create and maintain training files for VPL employees to ensure they are organized, complete, and up-to-date, this includes annual continuing education hours.
Oversee the off-site storage process, including sending documents out for archive, requesting documents for retrieval, and indexing.
Create and maintain electronic records of paper records for retention purposes.
Assists and helps manage the supplier qualification process and conduct supplier audits as needed.
Assist and lead internal audits to ensure internal policies are adhered to and regulatory requirements are met.
Review and send external notifications to clients regarding infectious disease results.
Coordinate and maintain records regarding data loggers for collection kit temperature monitoring program.
Participate in continuous improvement activities, projects, and development of new processes assigned.
Participate in audits and inspections by accrediting and regulatory agencies as assigned.
Ability to work within a matrixed environment.
Performs other duties as assigned.
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job at any time.
Basic Qualifications:
HS diploma or GED
4+ years of quality assurance/control experience in a medical service or regulated manufacturing industry.
OR
Associate degree
2+ years of quality assurance/control experience in a medical service or regulated manufacturing industry.
OR
Bachelor's degree
0-2+ years of quality assurance/control experience in a medical service or regulated manufacturing industry.
Preferred Qualifications:
Prior experience using Microsoft Office.
Quality background.
Experience in a customer / patient service or technical support field. Experience with automated databases and an electronic document management system.
Physical Requirements & Expectations:
Requires the ability to lift and carry up to 25 pounds.
Sit and/or stand for long periods of time.
Effectively manage conflict and emotional or stressful situations in a time sensitive manner.
The primary working condition associated with this position is an office environment.
While assisting with a cord blood/tissue shipment or investigating anomalies or customer complaints, it is frequently required to work-cross functionally; to enter and work in the laboratory, materials warehouse and/or LN2 storage room, in which the conditions may be variable from day to day.
Extended computer/keyboard use.
Potential hazards associated with LN2 vapor phase storage tanks and hazardous chemicals.
Job requires performance of duties that involve potential for exposure to blood, body fluids, or tissues.
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