Working with UsChallenging. 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: Principal Specialist, Sterility Assurance, QA OperationsLocation: Phoenix, AZKey Responsibilities:Sterility Assurance Program Management
Assures execution of aseptic manufacturing and testing operations in accordance with regulatory requirements
Owns and oversees the site Contamination Control Strategy.
Serves as liaison across departments for holistic monitoring of the aseptic operations
Participates in site Trend & Management Review
Communicates sterility assurance concerns to site leadership and works across functional areas to progress resolution
Represents Sterility Assurance in global regulatory agency audits and inspections
Interfaces with quality teams within the company to include the Americas, Europe, Australia, and Asia Pacific
Interacts with Marketing Authorization Holders (MAH) and Marketing Partners across the globe to ensure compliance and product quality
Conducts on-the-job training (OJT) and instructor-led training (ILT) to employees
Aseptic Observation
Owns or approves Aseptic Process Simulations (APS)
May participate in the Aseptic Observer Program, including but not limited to observations of critical aseptic processes, providing real time feedback to site teams, and facilitating triage/resolution to identified issues.
QA Responsibilities
Provides guidance in triage of events/incidents/escalations
May assist in performing routine walkthroughs/observations of the manufacturing and laboratory areas with an emphasis of maintaining and improving upon quality and 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
Assists team members in the deviation investigation process, including but not limited to acting as a Business/Technical Approver.
Participates in site commercial batch record review and disposition of product for global distribution, including but not limited to batch review, coordination with global departments/teams, and ensuring quality issues are communicated and resolved.
May assist in completion of Acceptable Quality Limit (AQL) inspections.
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
Participates in identification of repeat issues and ensure remedial actions are adequate.
Ensures that Standard Operating Procedures (SOPs), Forms, Drawings, Methods, etc. are acceptable for use and provide sufficient justification for change(s) prior to approval
Interfaces with all other quality groups within the company on quality system issues
Provides guidance to other employees in interpretation of complex data
Leads assigned projects/initiatives
Work is self-directed; confident in making decisions for major issues
Creation and review/approval of trend reports
Quality system record review and approval
Requires travel
Qualifications & Experience
Knowledge of science or engineering generally attained through studies resulting in a Bachelor's degree in a scientific or technical discipline.
A minimum of 8 or more years of relevant experience in a biologics or pharmaceutical manufacturing environment is required. Prior GMP Compliance / Quality Systems experience is preferred.
Strong project management skills (organization, collaboration, multi-tasking and communication), high degree of attention to detail, and the ability to perform well in a team-based environment are required.
Basic understanding of manufacturing processes, drawings and specifications and quality systems, including knowledge of applicable U.S. and E.U. cGMP regulations/guidance pertaining to change control.
Demonstrated ability to effectively establish proper priorities and to communicate complex information clearly and concisely, with demonstrated knowledge of subject matter related to quality and compliance.
Previous work experience with Track Wise/Veeva and responsibilities related to metrics and data analysis preferred.
Candidate must be familiar with and able to interpret relevant regulations, regulatory agency inspection expectations e.g. FDA, EMA, Health Canada, etc.
Excellent computer skills and proficiency with MS Office is required. Advanced knowledge of Excel preferred.
Advanced knowledge of cGMP
Ability to develop others through knowledge and experience
Ability to work with minimal Management oversight
Must be familiar with the requirements of Occupational Safety Health Administration (OSHA), Drug Enforcement Agency (DEA), United States Pharmacopeia (USP), Code of Federal Regulations (CFR) and European Pharmacopeia (EP)
Advanced written and verbal communication skills
Advanced knowledge of Quality Risk Management (QRM) and the ability to apply the concepts of risk management effectively
Ability to work effectively in teams
Ability to multi-task and be flexible
Advanced critical reasoning and decision-making skills
Advanced knowledge of quality management standards and industry guidance on quality systems
Advanced project management skills
Ability to provide input and build relationships internally and with cross-functional teams
Able to prepare written communications and communicate problems to management with clarity and accuracy
Considered the subject matter expert of the QS Operations department
Seeks and Implements process improvements intra and inter departmentally.
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.#LI-OnsiteBMSBLIf 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 CareersWith 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 ProtocolBMS 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 SquibbReq Number: R1589360Updated: 2025-02-14 01:56:10.393 UTCLocation: Phoenix-AZBristol 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.
