Analytical Quality Assurance-2

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. 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 Summary

As Analytical Quality Assurance, you will be responsible for the accurate and timely review, evaluation, and approval of qualification of analytical Reference Standards and Critical Reagents (RS-CR) in a dynamic, high-volume environment. You will work closely with various stakeholders across the organization to ensure compliant and efficient Quality Assurance review and approval of RS-CR qualification. Your role will involve maintaining a thorough understanding of applicable procedures and work flows and liaising with RS-CR operations and technical colleagues, as well as peers in the Analytical Quality and Compliance (AQ&C) team in QCEAS.  investigation sites to deliver high-quality, comprehensive investigation reports. You will apply critical thinking and risk-appropriate timelines to expedite the review and approval of critical qualification documents and supporting activities in enterprise electronic systems, ensuring timely escalations and accurate assessments. Additionally, you will engage proactively with both RS-CR and AQ&C partners to resolve compliance issues and support on-time completion of qualification activities to assure availability of RS and CR for the BMS analytical testing network. Your ability to prioritize, manage multiple tasks, and maintain collaborative relationships with stakeholders globally will be essential in driving the success of the analytical quality processes

Key Responsibilities

Responsible for accurate & timely Quality Assurance review, evaluation and approval of RS-CR qualification documents in a fast-paced, high-volume environment within established turnaround expectations (typically 3 days) while managing multiple concurrent assignments.

Responsible to maintain high level knowledge and understanding of applicable procedures appropriate for the qualification of RS-CR used in clinical and commercial GMP testing across the BMS network.

Ensure that critical thinking and risk-appropriate timelines are applied to assigned tasks, managing with due urgency. Use risk & time appropriate communication means to engage proactively, collaboratively, and timely with RSCR and AQC colleagues and senior management as appropriate to address quality and compliance issues associated with qualification activities (MS TEAMS preferred over email for time sensitive issues, as some critical qualification activities may require completion in 3 days or less).

Collaborate with RS-CR and AQ&C colleagues to understand near term book of work, and qualification documentation assigned to you, and the expected date of completion.

As required by management:

• Receive feedback from RS CR and AQ&C colleagues to assign AQ&C standards of Quality Assurance of RS CR qualification is maintained, and align collaboratively on improvements and/or process changes to support timely right first time qualification document approval
• Participate in AQ&C team meetings as required to assure common level of quality and compliance of RS CR qualification activities.
• Prompt and participate in ad-hoc meetings with RSCR colleagues as necessary to triage resolution to Quality Assurance concerns related to assigned qualification documentation work packages.

Qualifications & Experience

Degree/Certification/Licensure

• Bachelor of Science (Life Sciences, Pharmacy, Nursing, Chemical or Bio-Engineering or related field)

Required Competencies

• Fluent in English, with proven professional working proficiency in English for reading, writing and speaking
• Excellent communication with management, peers, and other functional areas
• Excellent understanding of GMP analytical testing.
• Ability to apply critical thinking in a high-volume, fast-paced environment
• Ability to prioritize while balancing multiple tasks with urgent completion dates
• Highly organized, detail oriented, efficient operator in a fast-paced environment
• Customer and partner focus, including the ability to listen to and incorporate feedback from key stakeholders
• Ability to build and maintain collaborative relationships with stakeholders in multiple geographic locations by engaging transparently, performing reliably, and delivering on commitments
• Excellent proficiency in use of electronic systems & databases to support daily use in a fast-paced environment (VEEVA Infinity, BMS Docs, LIMS, Sharepoint, Outlook, TEAMs, Word, Excel, SuccessFactors)

Experience – Responsibility and minimum number of years

• A minimum of 5 years of experience in a global Pharmaceutical/Bio-pharmaceutical/Device organization, in a Quality role
• Experience in qualification of GMP analytical testing reference standards and critical reagents is an advantage
• Prior experience in a GMP analytical testing laboratory is an advantage

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 a supportive culture, promoting global participation 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 an 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.

Supporting People with Disabilities

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/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.