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Senior Specialist, Quality Assurance

Phenom People
  • US
    Phoenix, Arizona, United States
  • US
    Phoenix, Arizona, United States

Über

Working At Bristol Myers Squibb Challenging. Meaningful. Life-changing. Those aren't 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. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. 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. Qualifications And Education
Bachelor's degree preferred 5-7 years of relevant work experience required, preferably in quality assurance/quality control An equivalent combination of education, experience and training may substitute Work is generally performed seated, but may require standing and walking for up to 20% of the time Work requires completion of an eye examination to demonstrate 20/20 correctable vision Work occasionally requires uniform/personal protective equipment (PPE) to work in a manufacturing, warehouse, or laboratory environment
Knowledge And Skills
Intermediate to Advanced knowledge of cGMP (FDA CFRs, EU Annex, etc.), Occupational Safety and Health Administration (OSHA), United States Pharmacopeia (USP) and European Pharmacopoeia (EP) Intermediate knowledge of Quality Systems: Deviations, Change Management, Product Quality Complaints Intermediate knowledge of Validation Program Intermediate knowledge of Risk Management Ability to multi-task and be flexible Strong teamwork skills Ability to complete routine tasks with moderate direction; consults management for advice on complex issues, confident in making decisions for minor issues Ability to directly contribute to the team performance and team results Ability to follow established procedures and performs work as assigned Ability to follow directions and communicate effectively with peers, team, and management Ability to leverage internal relationships within function to achieve objectives Able to recognize conflict and notify management Technical writing skills, able to follow technical reports Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
Key Responsibilities: Compliance
Provides sound quality guidance to all departments and ensures each decision maintains the Safety, Quality, Identity, Potency, and Purity (SQuIPP) of Bristol Myers Squibb (BMS) products and materials Adopts and constantly utilizes Quality Risk Management principles to make sound quality decisions Ensures the site meets all regulatory standards and consistently produces GMP compliant product
Customer Service
Provides efficient and effective customer support to the other departments at the site Works with Plant Operations to ensure compliance with and understanding of cGMPs, standard operating procedures (SOPs), and policies Supports other departments by reviewing and approving change controls, document change controls, investigations, validation documents, and corrective actions preventive actions (CAPAs) in a timely manner Assist with Product Quality Complaint (PQC) investigations Assist and may act at QA representative for site projects and initiatives Provides QA expertise as a resource to identify gaps, facilitate remedial actions, and ensure issues are resolved in a compliant manner
QA Knowledge And Skills
Possesses proficiency in reviewing and approving deviations, change controls, validation documentation, and other GMP documents (Material specification packets, analytical data, analytical reports, quality agreements, supplier non-conformances) Possesses a strong, detailed knowledge of site's manufacturing processes and procedures Proposes solutions for issues and works with management to resolve Actively contributes towards team goals
Requires travel less than 10% of time
  • Phoenix, Arizona, United States

Sprachkenntnisse

  • English
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