West Pharma Associate Quality Systems 

United States, Pennsylvania 

247406733

In this role, you will provide quality operations support through internal customer engagement. Lead and support continuous improvement for product and processes. Support plant functional areas such as engineering, operations, and maintenance by conducting data and document review/approval as it pertains to investigations and change management.

• Review Issue Bracketing based on issue documentation, process knowledge, and available control strategies, revising the bracket as necessary.
• Identify acceptable remediation activities for issues based on the issue documentation, investigations, and process capabilities.
• Perform Risk Assessment to support remediation justification.
• Use Trending, RCA, and Change Management tools to drive issue reduction activities.
• Use all necessary quality systems in compliance with system and procedural requirements.
• Interact with internal and external clients as needed.
• Meet individual and departmental goals as required.
• Understand and apply applicable FDA and ISO regulations/standards to the plant quality system.
• Other duties as assigned.

• Ability to honestly include two of the following statements in a self-assessment:
  • I have a demonstrated and reliable sense of the best of many options in the face of both limited or excessive information about the problem, the potential solutions, or both.
  • I am energized by garnering support for change through organizing, engaging, and inspiring those that will be responsible for implementing and maintaining the change.
  • I enjoy personally identifying and completing the fine details necessary to complete tasks or close out a project.
• Learn, understand and utilize complex sequences.
• Capability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude.
• Knowledge of West's fabrication and finishing processes.
• Strong verbal and written communication skills and attention to detail required.
• Prior use of LEAN or 6-Sigma tools to achieve a set target.
• Experience with the use of SAP, MasterControl, and Excel's "Named Tables", or Minitab.
• Experience with UX design theory or HCD practices.

• GED or HS diploma, Bachelor’s degree preferred
• 3+ years of experience in a cGMP environment

• Able to maintain confidentiality appropriately for role.
• Read and interpret data, information and documents to make independent and sound judgments.
• Learn and apply new information or new skills.