Supplier Quality Senior Specialist Devens, MA

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Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives.

Position Summary
The Supplier Quality Senior Specialist is responsible for work which supports the GMP/GDP Vendor and Material Management programs at the Devens Biologics site. This includes vendor qualification and management material qualification and management change management and supplier related non-conformance reporting and resolution.

Key Responsibilities

Qualification and management of GMP/GDP vendors including assessment of vendors creation and revision of Quality agreements and maintenance of the Approved Vendor List.
Lifecycle management of starting materials used for the manufacture of drug substance including material qualification and requalification reduced testing and direct dispense.
Assessment of supplier change notifications (SCN) and identification and completion of required actions within the BMS change management system.
Assists with internal or external deviations Supplier Corrective Action Requests (SCAR) and CAPA associated with nonconforming materials or services provided by vendors.
Performs review of documents including standard operation procedures technical documents / reports agreements qualifications and forms.
Executes oversight of on-site service vendors throughout the facilitiy in collaboration with the business owners and QA Operations.
Exercises sound decision making within generally defined processes to select methods for resolving routine work.
Identifes risks to Quality and business continuity and applies appropriate notification to management as appropriate.
Collaborates with cross-functional site and network stakeholders with a concise and solution oriented approach.
May represent the team on cross-functional projects and initiatives related to suppliers and materials.
May participate in external audits as a support team member under supervision of the lead auditor.