Specialist, E-Systems QA Engineering

Full Time
Summit, NJ 07901
Posted
Job description

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.

PURPOSE AND SCOPE OF POSITION:

The position’s primary responsibility is to help assure the quality, integrity, and compliance of site Information Technology (IT) systems, and maintain alignment between business process owners, end users, and other cross functional areas.

This position will assist in ensuring that IT systems are designed, setup, and function in a GMP-compliant manner which, in turn, will assist the site in safeguarding and maintaining the safety and quality of BMS products.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

  • Basic knowledge of cGMP guidance and regulations, including those pertaining to computerized system design, function, and use.

  • Basic knowledge of document management systems, quality systems (e.g. for deviations, change controls, etc.), MES (manufacturing execution systems, e.g. electronic batch records), inventory ERP systems, and validation tool software.

  • Basic written and verbal communication skills.

  • Basic problem-solving, critical-reasoning, and decision-making skills.

  • Basic time-management, organizational, and multi-tasking abilities.

  • Ability to work independently for extended periods of time

  • Basic ability to interpret / write technical documents.

  • Basic ability to solve routine and complex problems.

  • Working knowledge of Microsoft Word, Outlook, Excel, and other Microsoft Suite products

Education and Experience:

  • Bachelor of Science or Arts degree in scientific discipline.
  • Minimum of one – two (1-2) years of experience in the pharmaceutical or related industry.

DUTIES AND RESPONSIBILITIES:

  • Provides input and quality approvals for validation documentation that supports enterprise systems or applicable site and/or globally owned systems.

  • Adheres to use of best-practices during IT systems design, validation, and use.

  • Help the coordination with IT and other site departments to maintain and support electronic systems that are compliant, efficient, effective and reliable.

  • Collaborates with business stakeholders, technical support groups and Quality Assurance (as needed) to thoroughly investigate validation or engineering discrepancies.

  • Helps to ensure all required system documentation is maintained as changes in the system(s) are made. Documentation includes, but not limited to functional requirements, user requirements, and design specifications.

  • Reviews and approves documents, change controls, and protocols related to IT systems (site and global) under the supervision of Management

  • Applies data integrity regulations and guidance from governing agencies when participating in site and global projects related to computerized systems.

  • Supports deviations as needed.

  • Works on assigned project activities and ensures that activities are completed on time, with accuracy and compliance to established processes and procedures.

  • Supports continual alignment of the business process with other business functions and provides effective on-going end user support.

  • May be asked to draft, review, and edit SOPs, process flow and other business documentation.

WORKING CONDITIONS (US Only):

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

BMSCART

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.

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