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Specialist, Documentation Control at (BMS) Bristol-Myers Squibb in Summit, New Jersey

Posted in General Business 30+ days ago.

This job brought to you by eQuest

Type: Full-Time





Job Description:

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

 

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

This is a Tuesday - Saturday 11a - 8p Shift

PURPOSE AND SCOPE OF POSITION:

This position is responsible for supporting the CTDO Quality Systems Documentation Control group by coordinating activities related to GMP/GDP documentation systems and administrating associated SOPs and business processes that ensure compliance with established company/industry requirements.

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities:


  • Must have experience with cGMP manufacturing, Quality, and compliance.

  • Routinely recognizes and addresses quality opportunities to improve overall process/project efficiencies.

  • Comfortable providing input within the department and across the organization.

  • Able to write and review technical reports with clarity and brevity.

  • Provides guidance to other employees in technical writing skills.

  • Good understanding of software development Life Cycle (SDLC) and electronic document management systems.

  • Good understanding of records management systems and retention policies.

  • Completes routine tasks with little or no supervision.

  • Requires moderate direction to complete more complex tasks.

  • Recognizes risk for assigned project/processes and mitigates accordingly.

  • Propose solutions for complex issues and work with management to resolve.

  • Understands the basics of continuous improvement and improves efficiency and productivity within the group or project.

  • Comfortable providing training/guidance to system users as needed, and in instructor-led settings.

  • Able to recognize conflict and notify management with proposed recommendations for resolution.

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

  • Able to produce data reports with precision

  • Must be time organized and self-directed

  • Able to support internal and health authority inspections of facility

Education and Experience:


  • HS diploma or equivalent required.

  • College or university degree preferred.

  • 5+ years of related Quality experience in the pharmaceutical or related industry

DUTIES AND RESPONSIBILITIES:


  • Serve as a documentation system SME and provide guidance to system users as needed.

  • Serve as a Document Control Reviewer/Approver on documentation managed through the electronic GMP/GDP documentation management system

  • Prints/Issues Master Batch Records and Batch Record Related documentation

  • Prepares/Issues logbook and Quality Control Form requests

  • Assists with maintenance and administration of procedures related to job function

  • Systematizes and streamlines document workflows

  • Maintains training material for applicable document management systems

  • Provides end-user training on electronic document management systems

  • Works independently and has a direct impact on documents that are subject to regulatory authority inspection

  • Compiles applicable process metrics, identifies trends and escalates accordingly

  • Coordinates activities and projects with other functions, such as GMP Training

  • Ensures that documentation complies with established documentation system process/requirements

  • Provides support during internal and health authority inspections of facility

  • Monitors the periodic review process for documents

  • Communicates effectively with all cross functional and regional stakeholders on matters related to documentation systems

  • Distributes official documents to internal and external customers as needed

  • Works with team to implement records management policies and schedules for the electronic and physical records as needed

  • Carries out plans and actions in the documentation system to support acquisitions, new product launches, product in-license operations, new market and trading partner opportunities, and other quality management activities as assigned.

  • Supports Quality Systems harmonization efforts.

  • Performs other tasks as assigned

WORKING CONDITIONS (US Only):

Work is performed during the hours of 11am to 8pm, Tuesday through Saturday. 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. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

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 the resources to pursue their goals, both at work and in their personal lives.