Specialist QC Incoming

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Job Information
Bristol Myers Squibb
Specialist, QC Incoming
in
Phoenix
Arizona
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Position Specialist, QC Incoming Manager Associate Manager, QC Incoming Prerequisites (As Applicable) N/A Location Phoenix, Arizona
Purpose and Scope of Position:
The Specialist, QC Incoming is responsible for assisting with technical support for the QC Incoming department. The Specialist is also responsible for departmental deviations/investigations, change controls, CAPAs, supplier alerts, and risk assessments. In addition, the Specialist will support project related activities, standard operating procedure and specifications. Other job functions may include but not limited to training, trending, compendial review and continuous improvements.
Required Competencies: Knowledge, Skills, and Abilities
 Ability to interpret technical documents
 Ability to work under minimal supervision
 Ability to implement solutions independently
 Ability to prepare written communications and communicate problems to management with clarity and accuracy
 Ability to critically assess project(s) and allocate resources to efficiently achieve goals
 Intermediate teamwork and facilitation skills
 Intermediate knowledge of relevant scientific and technical principles
 Intermediate critical thinking, problem solving and decision-making skills
 Intermediate technical writing and verbal communication skills
 Intermediate knowledge of cGMP
 Intermediate knowledge of Pharmaceutical Compendia
 Intermediate knowledge of industry regulations
 Intermediate knowledge of Microsoft Office applications (Word, Outlook, SharePoint, PowerPoint and Excel)
 Intermediate knowledge of sampling/inspection process
 Intermediate to advanced project management skills
 Intermediate trending skills to include compilation, sorting and reporting
Duties and Responsibilities
Perform duties as a Subject Matter Expert for QC Incoming:
 Reviews and approves department related documents (SOP, Specifications, TRN, etc.)
 Consults management for advice on complex issues; work is self-directed; confident in making decisions for minor issues
 Provides support/collaboration/feedback to management concerning process improvements.
 Instructs and provides guidance on departmental risk assessments Ensure supplier quality through the following tasks:
 Generate risk assessments as necessary to support introduction of new/existing incoming materials
 Quality Technical Agreement (QTA) review
 Supplier alert support
 Participate in audits and/or provide input to auditors who go to our vendors Project Support:
 Assist with site and departmental projects and continuous improvement efforts
 Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers
 Supports project teams by managing activities and timelines, participating in discussions and providing effective communication with management Perform change management and investigations in support of QC Incoming:
 Initiate deviations, perform investigations, assist with determining root cause and appropriate corrective actions
 Generate, execute CAPA and ensure corrective actions and improvements are incorporated into the appropriate processes and procedures
 Generate, manage and execute Change Control
 Generate and execute change notice to support SOP/Specification revision/creation
 Generate risk assessments as necessary to support deviations and CAPAs Perform other tasks as required
Education and Experience
 High school diploma or equivalent required
 Bachelor’s degree preferred, in Chemistry or Related Field
 4 years’ relevant work experience required, preferably in a regulated pharmaceutical industry 
An equivalent combination or education and experience may substitute
. Working Conditions
 Position may require travel (most likely not to exceed 10%)
 Work is performed in a typical office environment, with standard office equipment available and used
 Work is generally performed seated, but may require standing and walking for up to 10% of the time.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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 the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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