MA, US
1 day ago
Sr. Specialist QA Technical Operations

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: Specialist, Quality Assurance OperationsLocation: Devens, MA

****** Shift 9:00 am to 5:00pm ******

Key Responsibilities:

Provides quality support to Devens Site through quality review and approval of deviations or change controls.  Supports technical transfer sub-teams and the review and approval of technology transfer documentation Support automation forums. Provide review and approval of automation change management. May lead automation change management forums.Support review of the cell bank disposition program. May track and review deliverables.May support projects and incoming transfers for cell banking operations. Review and approve Master Data for SAP and Syncade in support of tech transfer and projects. Review and approve Maximo work orders, OOTs, extensions for PMs and Cals.May participate in projects with limited decision-making.May provide quality support for Manufacturing Science and Technology and Validation reports as well as periodic assessments. Participates as requested in the response team for audits and inspections by world health authorities. Represents QA in cross functional meetings.  Makes sound decisions by coordinating with higher level QA personnel and exercising judgment within generally defined practices and policies. Applies appropriate notification to management as appropriate. Receives assignments which require the application of a defined process to complete the assignment.  As such, specific assignments are allocated based upon the recipient’s demonstrated capabilities with the degree of supervisory attention determined accordingly.  

Qualifications & Experience:

Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred. A minimum of 4 years of relevant experience in a regulated environment with at least 2 years focused on product quality.Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable. Knowledge of US and EU cGMP regulations and guidance.  Knowledge of electronic systems including any of the following: SAP, LIMS, Infinity, LES, Vitalize, Maximo, Vault, and Syncade desirable.Experience working in a team-based environment with a diverse group of people.Excellent writing and oral communication skills are required.Bachelor´s degree in science, engineering, or other related discipline. A minimum of 2 years' experience in biopharmaceutical quality or its equivalent with an additional 2-3 years of increasing responsibility preferred.Excellent written & oral communications skills.Capability to build alignment with peer level business partners.Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.Demonstrate capability with ability to make and act on decisions while balancing speed, quality and risk. Knowledge of biotech bulk and finished product manufacturing, analytical testing highly desirable.

Working Conditions

Work in a cGMP manufacturing environment following techniques which require one to maintain a high attention to detail.Properly use Personal Protective Equipment (PPE), gowning for restricted areas, handling chemicals, and work in a general office environment.

If you come across a role that intrigues you but does not 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.

The starting compensation for this job is a range from 96,230- 116,600 , plus incentive cash and stock opportunities (based on eligibility).

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 https://careers.bms.com/life-at-bms/.

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.

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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.

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.

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.

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