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Associate, Sample Administrator
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West Pharmaceutical Services
Exton, PA (In Person)
Full-Time
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Job Description
This is an onsite position requiring the team member to be onsite 5 days a week. Who We Are
At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. 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)
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.
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 #LI-KS2 #LI-ONSITE
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.