Quality Assurance Complaints Specialist

Cryoport Systems is the life science industry's most trusted provider of supply chain solutions for temperature-sensitive materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport Systems' proprietary Cryoport Express shippers, Cryoportal Logistics Management Platform, leading-edge Smartpak Condition Monitoring System and geo-sensing technology paired with unparalleled logistics expertise and 24/7/365 customer support, make Cryoport Systems the end-to-end temperature controlled supply chain partner that you can trust.

Job Title: Quality Complaint Specialist

Job Category: Staff

Department/Group: Cost of Goods Sold: Quality

Reports To: Quality Compliant Assurance Supervisor

FLSA Status: Exempt

Travel Required: N/A

Job Description

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 customer service, engineering, logistics, and quality assurance departments to identify and resolve 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 immediate evaluation of any

complaint of a critical nature that requires immediate attention to management, according to Cyroport's 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 QA Supervisor. Metrics may include complaints by product type, the reason for complaint, customer, or specific periods.

Coordination with complaint investigation and analysis personnel to understand root cause analysis supporting documentation to close the complaint properly.

Occasionally, the Complaint Specialist will be involved in specific CAPA's related to selected complaints to provide additional data during CAPA investigations and analysis.

Provide the first level triaging and technical evaluation of all incoming complaints

Coordinate with respective Global LC sites for equipment containment and necessary evaluation

Respond to any customer inquiries related to technical requests as a technical service support

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. 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.

Ability to drive Weekly Complaint Metric Meetings- Identify Commodity Impact/Loss

Able to review and analyze Daily Data Gap report on a daily basis to identify potential complaints or necessary equipment evaluation and containment

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