Product Analysis, Coordinator

Job Summary

In 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.

Essential Duties and 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.

Work Experience

• 0 - 3 years of experience required
• Experience working in a laboratory or cGMP/pharmaceutical environment preferred
• Laboratory administrative/Coordinator/Analyst role preferred

Preferred Knowledge, Skills and Abilities

• 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.
• Able to comply with the company’s safety policy at all times. #LI-AP1 #LI-ONSITE

Travel Requirements

5%: Up to 13 business days per year

Physical Requirements

Light-Exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects.

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

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.