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Job Details


Bristol Myers Squibb

Sr. Specialist, Quality Systems – Document Control

Technology

Computer Specialist

No

Warren, New Jersey, United States

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 Senior Specialist, Quality Systems is responsible for day-to-day QA Document Control activities at the Warren, NJ site, in accordance with Cell Therapy Development & Operations (CTD/CTO) policies, standards, procedures and global cGMPs. The position executes Document Control activities including but not limited to: Records Management System (RMS) administration; RMS support for new/current users; review and maintenance of controlled documents and management of logbooks. Periodic Review of documentation and support other functional areas of operations.

DUTIES AND RESPONSIBILITIES:

  • Serve as Document Control Administrator for the eDMS system in compliance with regulatory and BMS requirements;
  • Perform reviews on behalf of Document Control for documentation workflows within eDMS;
  • Management of Document Center and physical records archival activities including off site storage;
  • Manage the Periodic Review program and provide customer support as well as metrics;
  • Creation, Issuance and Reconciliation of logbooks;
  • Work is self-directed. Completes routine tasks with no supervision and more complex tasks with moderate direction;
  • Ability to recognize conflict with internal customers and notify management with proposals for resolution. Escalates concerns/issues to Document Control Management;
  • Supports Quality Systems harmonization efforts acting as site representative for system related projects, enhancements and process improvement;
  • Contributes to effective documentation system KPIs, metrics, and proactive issue resolution;
  • Drive Quality System harmonization with other sites and teams within the Cell Therapy organization;
  • Participates in site cross-functional teams and projects as SME for eDMS;
  • Recognizes risk and develops contingency plans;
  • Understands continuous improvement and improves efficiency and productivity within the group;
  • Demonstrates coaching skills and ensures end-users are properly trained on Document Control procedures;
  • Ensures that documentation complies with established eDMS standards and BMS overarching procedures;
  • Provides support during internal and health authority inspections;
  • Executes documentation system-related Quality Systems Objectives as assigned;
  • Assists with maintenance and administration of procedures related to job function;
  • Performs other tasks as assigned.

REQUIRED COMPETENCIES:

  • Must have cGMP experience related to Manufacturing, Quality, and Compliance and understand Good Documentation Practices;
  • Excellent verbal and written communication skills;
  • Demonstrates intermediate to advanced skills with standard Microsoft Office applications such Word, excel, etc;
  • Work independently with minimal oversight;
  • Demonstrates ability to plan/organize and allocate resources;
  • Action-oriented, customer-focused and skilled in decision-making;
  • Problem solver, planning and organization, resource allocation, and analytical thinking;
  • Contributes to the design and implementation of quality documentation and practices;
  • Leads communication regarding potential issues and coach site users to bridge knowledge gaps;
  • Able to effectively multi-task and execute project management skills to manage task timelines;
  • Fosters a team culture dedicated to enhancing customer satisfaction and building business partner relationships;
  • Possesses minor conflict management techniques/ideas designed to reduce the negative effects of conflict and escalates to management as needed;
  • Effectively communicate with management and internal customers with clarity and accuracy;
  • Works with an appropriate sense of urgency to support the Quality Systems team as well as other functional areas.

EDUCATION AND EXPERIENCE:

  • Relevant college or university degree preferred.
  • Minimum 5 years of relevant industry experience, of which 2 years is Document Control.
  • Experience with Veeva platform systems is preferred.
  • Equivalent combination of education and experience acceptable.
  • Previous experience in a gene or cell therapy facility is preferred.

WORKING CONDITIONS:

  • The incumbent may travel between NJ sites for training, meetings, or corporate events on occasion.
  • Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Light to moderate lifting may be required, up to 25 lbs.
  • There are no abnormal conditions caused by noise, dust, etc. Extended hours (>8 hours/day), weekend and/or holidays when required to support the business.

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. Employees holding this position will be required to perform any other job-related duties as requested by management based on business needs.

#LI-ONSITE

VETERAN

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.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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 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.