Associate Quality Assurance Engineer

Job Summary & Responsibilities:

This position supports the review of client records for any HCT/P that is sent for clinical trial participation, transplant, or research and review of batch records for contract processing. 

This role supports the day-to-day needs of the company regarding change management and controlled documents.

This role is also involved in various initiatives within the Quality department, which includes the overall processes of the maintenance and archival of records. Supporting internal quality activities that relate to the overall operation of the site’s quality program.

Responsibilities include, but are not limited to:

• Review of batch records for contract processing.

• Review of client records for HCT/Ps shipped or distributed.

• Support various aspects of ViaCord’s document management processes, this includes but not limited to:

• Create and maintain training files for VPL employees to ensure they are organized, complete, and up-to-date, this includes annual continuing education hours.

• Aid in maintaining the site’s electronic records of paper records for retention purposes.

• Assists in the change management process as it relates to assigning numbers and maintaining documentation.

• Assists in the management of company documents as it relates to creating, revising, and archiving controlled documents.

• Assist and lead internal audits to ensure internal policies are adhered to and regulatory requirements are met.

• Participate in continuous improvement activities, projects, and development of new processes assigned.

• Participate in audits and inspections by accrediting and regulatory agencies as assigned.

• 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. 

#LI-CH1

What do we offer?

We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:

• Medical, Dental, and Vision Insurance Options
• Life and Disability Insurance
• Paid Time-Off
• Parental Benefits
• Compassionate Care Leave
• 401k with Company Match
• Employee Stock Purchase Plan

Learn more about Revvity’s benefits by visiting our Bswift page. Log-In instructions are provided towards the bottom of the Bswift page.

For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information.