Quality Systems Specialist

This role is hybrid (3 days onsite) in Exton, PA. Candidates applying must be residing within a 50 mile commutable radius to the location.

 

 

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

This role is responsible for the coordination of West’s customer notification process which includes documentation and communication of West’s changes to Customers. Management of Change Control Review Board activities across cross functional teams for elastomer and medical device business units. This role will also be responsible for providing guidance, support, and training on West’s change control procedures and systems.

Essential Duties and Responsibilities

• Perform activities for creation, issuance and review of customer notifications relating to West change controls.  
• Coordinate customer notification process across cross functional teams, which includes direct communication with change owners to define appropriate change notification information, impacted customers and customer approval process, if needed. 
• Assist in activities of Change Control Review Board(s)(CCRB) and Medical Device Change Control Review Board (MDCCRB). This includes facilitating cross functional team discussions and documentation of meeting details and outcome.
• Engage with cross functional teams during change initiation to ensure information relating to customer notification/engagement is evaluated during change execution. 
• Support West customer facing teams to provide support on Customer Notifications/ communication of change.
• Hold monthly change meetings with customers, as applicable, to communication information on upcoming changes. Provide feedback to change owners and update customer notifications, as needed. 
• Maintain CCRB and MDCCRB metrics and customer notification metrics for trending, analysis, and reporting.
• Maintain the change control customer notification history, records and documentation to demonstrate compliance to regulations and company policies, procedures and requirements.
• Assist areas for training on change control and customer notification procedures and key compliance requirements as applied to West products and processes.
• Support initiatives for the development of digital strategies to enhance change control and customer notification processes. 
• Support corporate harmonization initiatives as they pertain to the quality management system.
• As appropriate, use knowledge and experience to identify initiatives to improve the effectiveness and/or efficiency of systems.
• Work independently with supervision.
• Other duties as assigned.

Education

• Bachelor's or Masters Degree in science preferred or equivalent experience in related discipline required

Work Experience

• Minimum 3 years Quality related experience required

Preferred Knowledge, Skills and Abilities

• Experience in regulated industry such as pharmaceutical or medical device. 
• In depth knowledge of cGMP, cGDP, relevant ISO standards 
• Experience with SAP systems