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Associate, Quality Systems (Jersey Shore, Pennsylvania, US)

Drug Packaging and Delivery Solutions - West · Jersey Shore, United States Of America · Onsite

  • Professional
  • Office in Jersey Shore
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This is a on-site position (5 days per week) working in our office at Jersey Shore, PA. Candidates applying must be residing within a 50-mile commutable distance to the job location.

 

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, 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.

Essential Duties and Responsibilities

  • 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.

Preferred Knowledge, Skills and Abilities

  • 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.

Education and Experience:

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

Additional Requirements:

  • 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. #LI-AP1 

Travel Requirements

5%: Up to 13 business days per year

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

 

 

 

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.