Product Analysis, Coordinator

West Pharmaceutical Services

2d•Onsite

About The Position

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 SummaryIn this role, you will be under the direction of the Product Analysis Manager to support activities related to product root-cause failure investigations on electro-mechanical drug delivery devices in a biohazard laboratory. You will additionally drive investigation process lean initiatives, manage communication with internal and external customers, train team members on new devices and assist with coordinating work for the lab technicians.

Requirements

0 - 3 years of experience required
Experience working in a laboratory or cGMP/pharmaceutical environment preferred
Laboratory administrative/Coordinator/Analyst role preferred
Able to comply with the company’s safety policy at all times.
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

Nice To Haves

Experience in conducting root cause investigations of field units.
Experience in laboratory test equipment operation and maintenance such as Instron, CT scanner, oscilloscope, power supply, multi-meter, and microscopes.
Background in Microsoft excel for the purposes of trending complaint data.
Background in medical device or pharmaceutical industry.
Knowledge of lean manufacturing and operational excellence concepts.

Responsibilities

Receive, log, and organize all incoming packages, ensuring proper documentation and maintaining order throughout the entire complaint workflow process
Maintains processes and procedures for receiving handling, storage, and disposition of returned devices according to regulations and company standards.
Maintains the product analysis lab including supplies, calibration, equipment maintenance, safety adherence, capacity improvements, and access
Coordinate lean process improvements for device investigations, lab procedures, and daily productivity as needed.
Communicates with customers regarding product issues and returned devices.
Creates and maintains a clean, neat, and safe work environment through identifying and resolving potential safety hazards.
Promotes teamwork and collaboration between departments to optimize processes and resolve problems.
Monitor upcoming deadlines and ensure all tasks are assigned and completed on time.
Demonstrates a “Customer Service” approach to all activities and assignments.
Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
Complies with the company’s safety and quality policies at all times, including proper handling of biohazard materials and components.
Exhibits regular, reliable, punctual and predictable attendance.
Complies with site and enterprise safety procedures when handling biohazard materials/components and potent drug compounds.