The Quality Assurance 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 is responsible for evaluating each complaint, entering the information into the company’s Complaint 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.
Monitor, track and report performance to established Key Performance Metrics striving to attain conformance to target objectives.
Any other duties, as assigned.
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 Clients.
Exhibit a passion for the company’s Vision, Mission, 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.
Experience with Biopharma, Life Science, Diagnostic Labs and/or related business
Experience with IATA DG regulations, specifically Class 6.2
Cryoport is the industry’s most trusted provider of cold chain logistics solutions for temperature-sensitive life sciences materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport’s proprietary Cryoport Express® liquid nitrogen dry vapor shippers, innovative C3™ 2-8°C solution, Cryoportal™ logistics management platform, leading-edge Smartpak II™ condition monitoring system and geo-sensing technology paired with unparalleled cold chain expertise and 24/7 customer support, make Cryoport the end-to-end cold chain logistics partner that you can trust.
Cryoport’s mission is to support life and health on earth by providing reliable and comprehensive logistics solutions for the life sciences through its advanced technologies and dedicated personnel. Cryoport will strive to develop mutually rewarding relationships with its employees, partners and suppliers and to conduct its business to the highest ethical and professional standards. Science. Logistics. Certainty.