**Working with Us** 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. Read more: careers.bms.com/working-with-us . **Position:** Specialist, Quality Assurance (QA) Operations **Location** : Phoenix ***** 3rd Shift 10pm-6am, Sunday-Thursday***** **Key Responsibilities** Shop Floor Quality (walkthroughs, real time review/assistance) to cover end to end manufacturing operations, maintenance activities and Quality Control laboratories + Triage manufacturing issues real-time to facilitate in determining initial product and process impact and immediate corrections + Provide guidance in triage of events/incidents/escalations + Assist and participate in deviation triage + Performs routine walkthroughs/observations of the manufacturing and laboratory areas with an emphasis of maintaining and improving upon quality and compliance + Real-time process and documentation review (e.g., batch records, logbooks, work orders, etc.) + Provide Quality and Compliance support to Manufacturing and Laboratory personnel; provide guidance during GMP events + Identification of documentation and process improvements + 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 + Adopts and constantly utilizes Quality Risk Management (QRM) principles to make sound quality decisions + Ensures the site meets all regulatory standards and consistently produces GMP compliant product + Routine Acceptable Quality Limit (AQL) visual inspection of unpackaged and packaged product Documentation/Record Review and Approval + Ensure that Standard Operating Procedures (SOPs), Forms, Drawings, Methods, etc. are acceptable for use and provide sufficient justification for change(s) prior to approval + Ensure that works orders (Maintenance and Metrology) are succinct and provide supporting documentation for the work performed + Batch related Incident Management tickets have been resolved + Identification and management of product quarantines + Ensure that Deviation Assessments have included all information/data/objective evidence as required by governing procedures Aseptic Observation + Observe critical aseptic processes and ensure that manufacturing is performed following good cleanroom behaviors and following aseptic techniques + Provide real time feedback to manufacturing, QC Microbiology and Maintenance to ensure adherence to approved documentation + Triage manufacturing issues real time to facilitate in determining initial product and process impact and immediate corrections + Identify areas of improvement and reinforce best practices Batch Review of finished product • Reviews batch records and assists in release of finished product from the facility to ensure compliance with approved procedures + Resolution to exceptions to the routine manufacturing process uncovered during Batch Review + Management of distribution holds **Qualifications & Experience** + High school diploma or equivalent required + Requires 20/20 correctable vision + Bachelor's degree preferred + 4 years of relevant work experience required, preferably in Quality Assurance or Quality Control + An equivalent combination of education, experience and training may substitute. + Basic knowledge of cGMP, Occupational Safety Health Administration (OSHA), United States Pharmacopeia (USP), Code of Federal Regulations (CFR), European Pharmacopeia (EP), etc. + 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 + Basic writing skills, able to follow technical reports + Provides QA expertise as a resource to identify gaps, facilitate remedial actions, and ensure issues are resolved in a compliant manner. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. \#On Site \#BMSBL   If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. **Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site Protocol** BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1589191 **Updated:** 2025-02-05 06:49:51.086 UTC **Location:** Phoenix-AZ 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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.