Sr Specialist, Quality Systems

 

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 independently managing the coordination of West’s customer notification process which includes documentation and communication of West’s changes to Customers. This role will also be responsible for independently providing guidance, support, and training on West’s change control procedures and systems.

 

Essential Duties and Responsibilities:

• Oversee team of Corporate Customer Notification Personnel
• Oversee the management of workload and development of personnel within the Customer Notification team.
• Independently perform activities for creation, issuance and review of customer notifications relating to West change controls.  
• Independently manage 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.
• 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.
• Lead 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 Customer Notification metrics for trending, analysis, and reporting.
• Maintain change control customer notification history, records and documentation to demonstrate compliance to regulations and company policies, procedures and requirements.
• Assist areas for training on customer notification procedures and key compliance requirements as applied to West products and processes.
• Support initiatives for the development of digital strategies to enhance 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.

 

Basic Qualifications: 

• Bachelor’s or Master’s degree in science preferred or equivalent experience in related discipline
• Minimum 3-5 years of quality related experience with preferred experience in Medical Device / pharmaceutical industry.

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
• Familiarity with document management databases, particularly MasterControl.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times

 

Travel Requirements:

• Approximately 5% travel, domestic and international, if needed

 

Physical & Mental Requirements:

• Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body.  Sedentary work involves sitting most of the time.  Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met
• Excellent communication and interpersonal skills must be coupled with pu