Title:  Sample Administrator

Job Summary

In this role, you will be responsible for sample lifecycle management for all projects as well as the data management for internal clients. You will interface directly with external clients, West plants, Lab Project Management, Lab Operations, and other West departments, as necessary. You will also make ensure all samples are handled correctly and meet all cGMP requirements. 
 

Essential Duties and Responsibilities

• Daily activities include receiving and documenting internal and external client samples arriving for testing, maintaining all shipping and sample files in accordance with cGMP regulations and internal QA initiatives.
• Responsible for the following daily activities associated with ownership of the total sample lifecycle. All activities require independent and/or collaborative decisions associated with testing plans, sample discrepancies, sample integrity, sample disposition, and client (internal and external) communication.
• Unpack and document incoming sample shipments
• Enter incoming sample shipments into electronic system
• Maintain shipping and sample documentation
• Accurately log-in test samples in conformance to project timelines
• Collaborate with the Project Management and Lab Operations teams on complex projects involving multiple departments
• Collaborate with internal customers and West affiliates
• Assist in communication to provide technical assistance to customers
• Contact internal and external clients for sample discrepancies and clarifications
• Contact internal and external clients regarding final sample disposition and returns
• Receive, log, and manage SAP submissions
• Maintain sample storage assignment inputs to keep accurate account and placement of sample inventory
• Review accuracy of sample log-in
• Ensure samples are correctly labeled, stored, and maintained under proper conditions
• Manage disposition of all laboratory samples (receipt, storage, return, retain, disposal, etc.)
• Aid in investigations as appropriate to ensure compliance with West procedures
• Provide audit support for both internal and external audits as needed
• Provide training and mentoring to new employees
• Assist in the monitoring of chambers 24/7 for alarms through the laboratory monitoring system
• Maintain procedures for sample management and handling
• Follow all safety practices and procedures
• Collaborate with Safety, Stability Specialist, Project Management and Lab Operations on incoming testing projects and shipping per regulations 
• Follow cGMP regulations and internal QA initiatives
• Apply required cGMP regulations and internal requirements
• Provide additional back up to other areas of laboratory operations as necessary including but not limited to glassware washing, and assist in support of lab functions
• Attention to detail, being personable, and multitasking are all required skills for this position
• Other duties as assigned

Education

• Associate degree or equivalent experience in related discipline
• High School Diploma is required

Work Experience

• 0 - 3 years of experience  

Preferred Knowledge, Skills and Abilities

• Experience working in a laboratory or cGMP/pharmaceutical environment preferred
• Laboratory administrative/Coordinator/Analyst role preferred
• Sample information management system experience (SAP and/or LIMS, LabVantage preferred)
• Laboratory Monitoring system for different environments
• Has worked in a cGMP environment
• Education in shipping, receiving, and inventory maintenance of regulated substances and/or hazardous materials
• Familiar with national and international shipping carrier requirements
• Analytical testing experience/knowledge 
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description 
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target 
• Able to comply with the company’s safety and quality policies at all times

Travel Requirements

Physical Requirements

Additional Requirements

• Must be able to stand for long periods of time
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms
• Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to follow directions, multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems