Analytical Quality Assurance-2

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

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.

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