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Senior Specialist, QA Engineering
Taleo BE Warren, NJ
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$78k-97k (estimate)
Full Time 1 Week Ago
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Taleo BE is Hiring a Senior Specialist, QA Engineering Near Warren, NJ

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 rich in diversity. 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.

Title: Senior Specialist, QA Engineering

Location: Warren, New Jersey

Position Summary

The Senior Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, review of validation and qualification documents for all equipment and facility activities. This position is a member of the Cell Therapy Development and Operations (CTDO) organization, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.

Qualifications & Experience

  • B.S. degree required.

  • 2 - 4 years of experience in the pharmaceutical or related industry.

  • Equivalent combination of education and experience acceptable.

  • Must have knowledge and experience with GMP, Quality and compliance.

  • Previous experience as a computer system validation / quality assurance / quality control analyst for life sciences company regulated by the FDA is preferred.

  • Experience in design of user requirement specifications, IQ/OQ/PQ protocols, user acceptance testing and other equipment/facility qualification documentation.

  • Must be fluent in standard Microsoft Office software; experience in asset management software (e.g. Blue Mountain RAM) and quality systems software (e.g. Veeva, eQRMS).

  • Drives use of best practices during IT systems design, validation, and use.

  • Must be able to recognize and group technical / scientific attributes and drive science-based decisions in most technical areas.

  • Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.

  • Must be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.

  • Intermediate knowledge of quality systems including CAPA, change control, and document management systems.

  • Requires minimal direction to complete tasks, authority to make daily decisions that impact their team.

  • Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.

  • Consults management for advice on complex issues.

  • Able to prepare written communications and communicate problems to management with clarity and accuracy.

  • Drive strong collaboration within the site and across the network.

Key Responsibilities

  • Functional responsibilities include ensuring accurate and timely maintenance of validation and qualification documents for all equipment and facility activities; investigations and evaluation of change control and supports Quality Risk Management program activities at the site.

  • Ensure IT systems are designed, setup and function in a GMP-compliant manner to safeguard and maintain the safety and quality of BMS’s products.

  • Provides QA oversight on key software development life cycle (SDLC) processes such as problem, incident, change, release and deviations.

  • Support the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.

  • Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures.

  • Support ECQ, Facilities, QC and manufacturing equipment-related investigations in ensuring appropriate and thorough impact assessment, root cause analysis and corrective/preventive actions are documented and implemented.

  • Ensures compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.

  • Work with Engineering/Facilities/ECQ management to ensure functional activities comply with global regulatory requirements.

  • Sponsor and support the change initiatives and the implementation of process improvement initiatives.

  • Ensure site is compliant with global and regulatory data governance and data integrity requirements.

  • Support any other goals and objectives of the site Quality Assurance organization, as needed.

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 an inclusive culture, promoting diversity 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.

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.

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

#LI-Onsite

BMSCART

VETERAN

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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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.

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

Job Summary

JOB TYPE

Full Time

SALARY

$78k-97k (estimate)

POST DATE

04/30/2024

EXPIRATION DATE

05/16/2024

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