Manager, QC Instrument Specialist

Manager, QC Instrument Specialist

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.

Lead qualification of quality control analytical instruments and other lifecycle activities. Design, manage, and implement applicable validation documents, such as test scripts, User Requirement Specification, Design Qualification, validation plans, Data Integrity assessments, risk assessments, installation/operation qualification protocols, and qualification summary reports. Champion qualification deviations/defects, identifying root causes and Corrective Actions/Preventive Actions. Participate in an Instrument Lifecycle Community of Practice to include multiple commercial QC sites, with a focus on sharing best practices, identifying key risks, reviewing regulatory and inspection trends, and driving towards lifecycle/qualification standardization. Own change controls impacting QC equipment/software. Update asset management database to reflect new assets, calibrations, and preventative maintenances. Act as the liaison between Digital Plant (Information Technology) and lab departments. Perform instrument periodic assessments/decommissioning. Coordinate with external vendors for support.

40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m.

Minimum Requirements:

Bachelor of Science degree in Engineering Management or a related field plus 4 years of post-baccalaureate experience in analytical instrument hardware/software qualification/validation.

Experience must include the following:

• Laboratory systems such as Empower, NuGenesis and other software programs;
• Current cGMP (Good Manufacturing Practices) regulatory requirements, computerized analytical systems;
• Quality management system including document control/management, owning change controls, investigations, deviations, electronic validation database execution, and asset management database;
• Organizational/team leadership;
• Regulatory body audit;
• Computer system validation; and
• Coordinating with and influencing global level validation teams and processes.

The required skills do not need to be maintained over the full term of required experience.

May work remotely 1 day per week within normal commuting distance of Devens, MA.

To apply, email resume and reference R1592884 to resume.com@bms.com.

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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.

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.

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/.

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