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Bristol Myers Squibb Method Trending Lead in Devens, Massachusetts

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In 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.

Quality Control Method Trending Lead

Summary:

To support QC methods and instrument performance by monitoring and analyzing invalid rates, using statistical tools, to monitor variation of reference standard data and critical reagents allowing for reaction to adverse trends within the QC Labs ensuring consistent performance. ​

Responsibilities:

  • Monitor and analyze analytical method performance using statistical tools.

  • Provide support during PMI/LES application maintenance related activities.

  • Support data/analysis requests for APR/APQR, investigations, and analytical method changes within PMI and LES applications.

  • Support optimization and improvements of analytical method performance data assessments and trending.

  • Lead Manufacturing SPC QC evaluations.

  • Lead QC MP-SAE evaluations.

  • Support investigations related to release and method performance (OOT).

  • Support data mining, collection, and verification to support local trending and network initiatives.

  • Support or lead writing of technical reports, APQR, SAE Checklists and MPSAE Checklists.

  • Participates in audit response development and management of response timeline and CAPA identification.

Qualifications:

  • Minimum BS degree with 4+ years relevant life-science industry experience (pharmaceutical/biologics) preferably in a QC environment.

  • Knowledge of biologics laboratory settings, GMPs, and support disciplines and the basic principles of each. Knowledge and understanding of regulatory and technical data trending requirements and associated processes.

  • Strong understanding/knowledge of Aegis (Discoverant), SAP, Sample Manager, LES, Empower and Infinity preferred.

  • Ability to work collaboratively with all employees at all levels.

  • Proficiency in Windows XP, Windows Server 2000, Windows 2003 Server, Oracle, SQL Server.

  • Project management, problem-solving and decision-making skills.

  • Ability to perform well in a team-based environment.

  • Experience determining objectives of significant projects or assignments.

BMSBL

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.

Company: Bristol Myers Squibb

Req Number: R1530792-en-us

Updated: 2020-12-03 00:34:02.081 UTC

Location: Devens,Massachusetts

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.

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