Tech 1, Quality Assurance

Katalyst CRO; Tempe (AZ); On-site; USD 42,000 - 56,000; Full time

Job summary

Katalyst CRO is seeking a Technician for Field Assurance to oversee daily operations in the Field Assurance Lab, handling complaint samples shipping and receiving, and coordinating image reviews promptly. The role emphasizes GDP/GLP adherence and a professional interface with internal and external customers.

Responsibilities include documenting samples, managing kit requests (domestic and international), tracking shipments, and maintaining documentation and trackers.

Qualifications

• High school diploma or GED, or equivalent.
• Associated degree or equivalent experience.
• Experience with sample handling in a lab environment preferred.

Responsibilities

• Document complaint samples received in the Field Assurance Lab for evaluation.
• Support daily requests for sample return kits, ship domestically and internationally, track and communicate with requestors.
• Ensure accurate and timely shipping of sample return kits.
• Track shipping inventory and order supplies through approved vendors.
• Oversee image/video review requests; run TrackWise queries and maintain trackers.
• Maintain GDP when recording preliminary and sample analysis results.
• Escalate unexpected issues to Supervisor/Manager.
• Maintain GLP in line with biosafety lab practices.
• Maintain a clean, safe work environment.
• Maintain professional relationships with customers and support staff.
• Store and dispose of complaint samples per procedures.
• Support continuous improvement of lab processes.
• Understand and follow procedures and regulatory requirements.

Skills

Communication

Detail-oriented

Independent work

Problem solving

MS Office

Lifting 50 lbs

Education

High school diploma / GED

Associate degree or equivalent

Tools

TrackWise

FedEx shipping system

Job description

Job Description

This Technician for Field Assurance (FA) role involves overseeing daily operations in the Field Assurance (Complaint Handling) Lab. Responsibilities include managing the shipping, receiving of complaint samples, and conducting image reviews associated with complaints promptly. Familiarity with biosafety and good laboratory practices, as well as experience working in a clean room environment, is preferred.

Job Description

This Technician for Field Assurance (FA) role involves overseeing daily operations in the Field Assurance (Complaint Handling) Lab. Responsibilities include managing the shipping, receiving of complaint samples, and conducting image reviews associated with complaints promptly. Familiarity with biosafety and good laboratory practices, as well as experience working in a clean room environment, is preferred.

Responsibilities (including Supervisory And/or Fiscal)

• Documentation of complaint samples received in the Field Assurance Lab for evaluation purposes
• Support daily requests for sample return kits to be shipped domestically and internationally, maintain tracking documentation, communicate in a timely manner with the requestor, assembly sample return kits and warehouse pickup and drop-offs
• Ensure accurate and timely shipping of sample return kits
• Track shipping inventory and order supplies through approved vendors
• Oversee image/video review requests received as a task, run a query in TrackWise to capture all requests and process requests in a timely manner. Additionally, maintain the image/video review tracker and follow up on any pending requests.
• Maintain good documentation practices (GDP) when recording preliminary and sample analysis results
• Escalate all unexpected issues to the Supervisor/Manager
• Maintain good laboratory practices (GLP) consistent with biosafety laboratory practices
• Maintains a clean work environment
• Maintains a professional working relationship with internal and external customers and support staff
• Storage and disposal of complaint samples in accordance with applicable procedures
• Support continuous improvement of lab processes
• Understand and follow procedures and regulatory requirements

Requirements

• Good written and verbal communication skills
• Detail-oriented
• Ability to work independently and in cross-functional teams
• Basic problem-solving / troubleshooting skills
• Must have proof of Hep B series, be willing to undergo Hep B series, or sign waiver
• Proficient in MS Office
• Requires the ability to lift at least, but no limited to 50 lbs.

Preferred Qualifications

• Knowledge of the FedEx shipping system to conduct precise shipping transactions
• Previous warehouse experience

Preferred Qualifications

• Medical industry (GMP) and/or lab experience preferred

Education And/or Experience

• High school diploma, GED, or equivalent
• Associated degree or equivalent experience

Physical Demands

• While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment

• While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. Client is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.