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QA Specialist Position Summary

If you’re interested in joining our team, please send your resume and cover letter to hr@cryoport.com. Make sure to include the job title of the position you are interested in the subject line of your email. 

Job Title: Quality Assurance Complaint Specialist
Job Category: Staff
Department/Group: Quality Assurance and Regulatory Affairs
FLSA Status: Exempt
Reports To: VP - Quality Assurance and Regulatory Affairs
Travel Required: N/A

Position Summary
The Complaint Specialist is a technical position that is responsible for receiving, reviewing, and documenting customer complaints of Cryoport’s products according to current Quality Management System requirements. This position primarily interfaces with the customers service, engineering, logistics and quality assurance departments in the identification and resolution of customer complaints.

The Complaint Specialist will be evaluating each complaint, entering the information into the company’s system and ensuring the proper and timely handling of each complaint. This includes immediately evaluation of any compliant of a critical nature that requires immediate attention to management, according to Cryoport procedures.

Responsibilities include but are not limited to:

  • Establish and maintain complete complaint files and databases for all customer complaints, according to established company procedures.
  • Maintenance of all complaint procedures, files and records according to established Cryoport procedures.
  • Establish and maintain quality metrics for all product complaints, according to the direction of the VP QARA. Metrics may include complaints by product type, reason for complaint, customer, or specific time periods.
  • Coordination with complaint investigation and analysis personnel to understand root cause analysis in support of documentation to properly close the complaint.
  • Occasionally, the Complaint Specialist will be involved in specific CAPA’s related to selected complaints to provide additional data during CAPA investigations and analysis.
  • Possible involvement and interface with internal and external auditors, including customers, related to the activities and documentation related to the complaint system and processes.
  • Interact with other functional groups inside and outside the Quality department.

Competencies:

  • Problem Solving. A clear understanding of the compliance requirements is preferred, and the ability to collect objective evidence for investigations can help solve problems, typically in situations where general standardization should exist, but may not be operating effectively.
  • Team Player. Ability to be involved in teams and meetings at every level of the organization. 
  • Must possess excellent verbal and written communication skills.
  • Must have experience or familiarity in writing company policies and procedures and associated documents. 
  • Solid Knowledge of the Quality documentation process, Document Control practices with an EDMS
  • Must have strong self-motivation and the ability to work independently.
  • Organization and prioritization skills with an excellent attention to detail.
  • Able to understand and comply with established company policies and procedures.
  • Passion and alignment with our mission, vision, values & operating principles.
  • Passion for working in a values-based company in alignment with a learning organization.
  • Demonstrates a passion and a responsibility for consumer.
  • Exhibit a passion for the company’s Essence, Global Imperatives, Corporate Direction.
  • Desire to own decisions and take responsibility for outcomes.
  • Willingness to continually embrace personal and professional development.

Qualifications and Education Requirements:

  • Bachelor’s Degree in Engineering or Science related field
  • 2 years prior experience in Quality Assurance or Quality related field.
  • Must be familiar with Quality Standards.  Experience with Good Distribution Practices (GDP), ISO standards (i.e. ISO 9001), and Sarbanes Oxley.
  • Proficiency in Microsoft Office.
  • Experience in Quality Management Systems.

Preferred Skills:

  • Experience with Biopharma, Life Science, Diagnostic Labs or related business
  • Experience with IATA DG regulations, specifically Class 6.2

What our clients are saying

“I contacted Cryoport to transport stem cells from Denver, Colorado, to Albuquerque, New Mexico, and the service provided was excellent. It was a hassle-free transport. I was especially impressed with the continuous communication throughout the transport and particularly appreciated the fact that not only did my shipment arrive in good condition, but Cryoport also made all of the arrangements for the return of the shipper so that I didn’t have to. Our facility will definitely use Cryoport’s service in the future and would recommend it to others.”
Stem Cell Transplant Coordinator – Cryoport Customer
“Cryoport does an amazing job of handling the shipping and logistics for transporting cryopreserved materials. We have switched to them for all of our exports.”
Bioengineering Core Employee – Cryoport Customer
“As a customer I'm very pleased with the service I received from Cryoport. Cryoport’s team always answered my questions, provided help in a professional manner and were extremely attentive.”
Cryoport Customer
“Had I known how great Cryoport’s dry vapor shipper and logistics system worked, we would have used Cryoport for all our previous shipments to the U.S. In the past we have used dry ice and several times we lost valuable cells because our shipments would sit in customs forever and the dry ice would evaporate. Cryoport eliminated that concern altogether. I will certainly be utilizing Cryoport’s services for future shipments.”
Principal Investigator – Cryoport Customer
“By using Cryoport I experienced much less stress as my shipment went through customs!”
Principal Investigator – Cryoport Customer
“I called Cryoport after hours for information about a shipment I needed to schedule and received absolutely outstanding customer service. Cryoport provided me with a lot of helpful information and great advice. It's rare and refreshing to receive such great service.”
Cryoport Customer
“Not only did my cells arrive safely, Cryoport’s service was professional and efficient. I highly recommend Cryoport.” 
Hematologist – Cryoport Customer

“Working with Cryoport was a truly remarkable difference compared to my experience with other shippers. With the previous shipping company I was working with, it took almost three months to establish a ‘deep frozen account’ and required numerous hoop-jumping shenanigans only to ultimately be informed that the company could not arrange a shipment to or from Israel, which they were informed from the start was our desired shipping source.

Our sales rep at this organization was as dumbfounded by our experience as we were. To his credit, after his company declined our business, he suggested I contact Cryoport. I have written thanking him for his suggestion and to let his ‘powers-that-be’ know how different my experiences were.”

Cryoport Biopharma Customer
“When compared to other shippers, I am highly satisfied with Cryoport’s pricing and service.”
Lab Manager – Cryoport Customer
“Our organization is more than impressed by our experience with Cryoport. We feel confident our material is being well-managed throughout transit. Cryoport provides extraordinary customer service and continuously they not only meet, but exceed our expectations. Late yesterday afternoon Cryoport worked tirelessly to coordinate a shipment to Japan and today seemed to effortlessly manage a late-day return. It is a pleasure working with Cryoport.”
Senior Supply Chain Analyst – Cryoport Customer
“Cryoport’s service is easy, straightforward and very convenient. We used to run into issues with transporting specimens to outside labs and Cryoport has eliminated this hurdle. Knowing Cryoport has it handled helps me sleep at night.”
Professor of Anatomy, Histology and Cell Biology – Cryoport Customer
“I'd like to commend Cryoport for their fantastic service. Our collaborator was also similarly impressed and will be recommending Cryoport to her colleagues. In addition to the great service and quality product, Cryoport’s pricing is second to none. We look forward to working with Cryoport for all of our future temperature-sensitive shipments."
Lab Manager – Cryoport Customer

"I want to thank everyone at Cryoport who was involved in the rapid recovery of the missing Cryoport shipper containing a patient’s tumor tissue. By promptly locating the shipper and recharging it while in transit, the patient was able to receive the vaccine manufactured from this tissue on time. We are so very appreciative of Cryoport’s customer service. Without the services that Cryoport provides, our clinical trials would not be available to patients."

Director of Clinical Operations — Cryoport Customer
“Cryoport provides a reliable solution to ship temperature-sensitive biologics around the world. The Cryoport solution is easy for scientists to use. They respond quickly, have great customer service and anticipate problems. I am able to speak to someone 24/7 who is an expert on MY package. It is personal service focused on deep frozen life sciences. I consider Cryoport to be an extended member of my team.”
Product Operations Specialist – Cryoport Customer