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Title:  Sr. Sample Administrator, Team Lead

Requisition ID:  55914
Date:  Aug 5, 2022
Location: 

Exton, Pennsylvania, US

Department:  Laboratory
Description: 

 

Who We Are:-

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

In this role, the Sample Administrator Lead will be responsible for leading the sample lifecycle management for all projects as well as the data management for internal clients. This individual would serve as a Subject Matter Expert and a point of escalation for system and process issues in Sample Administration. This individual would interface directly with external clients, West plants, Lab Project Management, Lab Operations, and other West departments, as necessary. As a senior role, this person will make independent, time-critical, on-the-fly decisions on a daily basis to 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 file inventory in accordance with cGMP regulations and internal QA initiatives.
  • Responsible for the following daily activities associated with ownership of the total Sample life cycle. All of the 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 file 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 to understand customer needs
    • Communicate and provide technical assistance to customers, which may include external customer visits to facilitate technical discussions
    • 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
    • Act as Project Management for Plant Projects including client contact, troubleshooting, sample request, result reporting.
    • Maintain sample storage assignment inputs to keep accurate account and placement of sample inventory
    • Review accuracy of sample log-in
    • Manage disposition of all laboratory samples (receipt, storage, return, retain, disposal, etc.)
    • Report project information and testing results to internal clients
  • Team Lead Responsibilities:- 
    • Delegate and manage day to day priorities for the group including Project log-in, Plant sample receipt, and Project receipt
    • Determine log priority and process in collaboration with the Project Management team
    • Lead and collaborate on investigations as appropriate to ensure compliance with West procedures
    • Provide additional back up to stability as necessary including monitor chambers 24/7 for alarms through the laboratory monitoring system and subsampling for distribution across testing areas
    • Provide recommendations and lead initiatives to improve sample administration area, processes, and procedures
    • Serve as the Subject Matter Expert in the team and provide training to junior personnel
    • Serve as the point of escalation with any system and process issues
    • Perform activities related to Sample Administration as a back-up for the Supervisor, Sample and Project Planning
  • Aid in investigations as appropriate to ensure compliance with West procedures
  • Provide audit support for both internal and external audits as the Sample Administration subject matter expert
  • Provide training and mentoring to new employees
  • Provide additional back up to stability as necessary including monitor chambers 24/7 for alarms through the laboratory monitoring system and subsampling for distribution across testing areas
  • Follow safe handling practices and procedures
  • Collaborate with Safety, Stability Coordinator, 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 glassware washing, stability sample handling, 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:

  • Bachelor’s Degree in a scientific field
  • Minimum 5-8 years of experience in a pharmaceutical or laboratory environment with sample administration responsibilities
  • Excellent communication skills

 

Preferred Knowledge, Skills and Abilities:

  • Sample information management system experience (SAP and/or LIMS, LabVantage preferred)
  • 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

 

Travel Requirements:

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

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West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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