Title:  Associate, Sample Administrator

Job Summary

In this role, the Sample Administrator will be responsible for sample lifecycle management for all projects as well as the data management for internal clients. This individual will interface directly with external clients, West plants, Lab Project Management, Lab Operations, and other West departments, as necessary. This person will 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 & on call schedule
• 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

Basic Qualifications

• Associate degree or equivalent experience in related discipline
• Minimum 0-1 years of experience preferred in a pharmaceutical or laboratory environment with sample administration responsibilities
• Excellent communication skills

Travel Requirements

• Minimal travel, up to 5% (Meetings, Trainings, collaboration)

Physical and Mental Requirements:

• • Able to use hands
  • Able to lift 10-20 lbs
  • Able to handle hazardous materials, chemicals, and drug products
  • Able to enter closed spaces (temperature stability chambers) for short periods of time
  • Sitting and/or standing for extended periods as well as getting to and from offices and building sites
  • Must maintain the ability to work well with others in a variety of situations
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize
  • Must also be able to maintain confidentiality and resolve conflicts
  • Observe and interpret situations
  • Learn and apply new information or new skills
  • Work under deadlines with constant interruptions
  • Excellent organizational and record-keeping skills
  • Excellent communication and interpersonal skills.

Preferred Knowledge, Skills and Abilities

• Sample information management system experience (SAP and/or LIMS, LabVantage preferred)
• Laboratory Monitoring system for different environments
• Has worked in a cGMP environment
• 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 policy at all times
• Able to comply with the company’s quality policy at all times.
• 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 is a plus

Shift

1st Shift