Senior Specialist, Quality Assurance
Expiry Date :
Sun, 25 Apr 2021 23:59:59 GMT
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At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Purpose and Scope of Position The Sr Specialist, Quality Assurance is responsible for reviewing GMP documentation and ensuring that commercial products and materials meet required quality characteristics. QA is responsible for the technical aspects of quality assurance as it relates to the products and changes or events that may impact the products. The Sr Specialist, QA works within the QA team to establish and maintain quality assurance systems necessary for ensuring operations are in compliance with current Good Manufacturing Practices and to ensure the quality characteristics of components, in-process and finished products are met. The Sr Specialist, QA will also work cross-functionally to ensure that GMPs are followed while maintaining an efficient and effective program to meet production requirements. Required Competencies: Knowledge, Skills, and Abilities – Requires detailed knowledge of cGMP, OSHA, USP and EP – Ability to critically assess project(s) and allocates resources to efficiently achieve goals – Ability to multi-task and be flexible – Advanced teamwork and facilitation skills – Advanced critical reasoning and decision making skills – Able to more fully interpret results and situations and articulate recommendations for resolution – Ability to broaden technical and scientific knowledge – Basic knowledge of fundamental scientific problems – Ability to prove input and build relationships internally within function and with cross-functional teams – Able to implement solutions independently – Able to write and review reports with clarity and brevity – Able to produce data reports with precision – Able to prepare written communications and communicate problems to management with clarity and accuracy Duties and Responsibilities Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. – Performs QA review of Change Controls – Responsible for QA review and approval of deviations and CAPAs – Responsible for QA review and approval of materials and products to include commercial product review and release – Responsible for QA review and release of in-process and finished product – Responsible for QA review and approval of Maintenance Work Orders and Metrology documents – Responsible for QA review and approval of Change Control Requests (e.g., DCCs, CCRs) to ensure the proposed changes are justified, supported by data and have been appropriately validated where applicable – Performs Product Quality Complaint (PQC) investigations – Interfaces with all other quality groups within the company on quality systems issues – Performs all other tasks as assigned – Conducts on-the-job training (OJT) and instructor-led training (ILT) to employees – Consults management for advice on complex issues; work is self-directed; confident in making decisions for minor issues – Recognized Subject Matter Expert within the group – Leads assigned projects/initiatives – Provides guidance to other employees in interpretation of complex data – Works with Plant Operations to ensure compliance with and understanding of cGMPs, SOPs,and policies – Responsible for conducting QA review and approval of Validation, Engineering and Quality Control protocols, procedures, test plans and summary reports. This responsibility includes IQ/OQ/PQ, method validation approvals and conducting data integrity audits. Education and Experience: – High school diploma or equivalent required – Bachelors degree preferred – 5 years of relevant work experience required, preferably in quality assurance/quality control – An equivalent combination of education, experience and training may substitute Working Conditions: – Work is generally performed seated but may require standing and walking for up to 20% of the time – Work requires satisfactory completion of an eye examination to demonstrate 20/20 correctable vision – Work occasionally requires uniform/PPE to work in a manufacturing, warehouse, or laboratory environment Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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. Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to . 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