Senior Specialist, Quality Assurance

Working At Bristol Myers SquibbChallenging. 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 EducationBachelor's degree preferred5-7 years of relevant work experience required, preferably in quality assurance/quality controlAn equivalent combination of education, experience and training may substituteWork is generally performed seated, but may require standing and walking for up to 20% of the timeWork requires completion of an eye examination to demonstrate 20/20 correctable visionWork occasionally requires uniform/personal protective equipment (PPE) to work in a manufacturing, warehouse, or laboratory environmentKnowledge And SkillsIntermediate 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 ComplaintsIntermediate knowledge of Validation ProgramIntermediate knowledge of Risk ManagementAbility to multi-task and be flexibleStrong teamwork skillsAbility to complete routine tasks with moderate direction; consults management for advice on complex issues, confident in making decisions for minor issuesAbility to directly contribute to the team performance and team resultsAbility to follow established procedures and performs work as assignedAbility to follow directions and communicate effectively with peers, team, and managementAbility to leverage internal relationships within function to achieve objectives Able to recognize conflict and notify managementTechnical 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:ComplianceProvides 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 materialsAdopts and constantly utilizes Quality Risk Management principles to make sound quality decisionsEnsures the site meets all regulatory standards and consistently produces GMP compliant productCustomer ServiceProvides efficient and effective customer support to the other departments at the siteWorks with Plant Operations to ensure compliance with and understanding of cGMPs, standard operating procedures (SOPs), and policiesSupports other departments by reviewing and approving change controls, document change controls, investigations, validation documents, and corrective actions preventive actions (CAPAs) in a timely mannerAssist with Product Quality Complaint (PQC) investigationsAssist and may act at QA representative for site projects and initiativesProvides QA expertise as a resource to identify gaps, facilitate remedial actions, and ensure issues are resolved in a compliant mannerQA Knowledge and SkillsPossesses 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 proceduresProposes solutions for issues and works with management to resolveActively contributes towards team goalsRequires travel less than 10% of time Phenom People