Specialist, Documentation Control

Location
Summit West, NJ, United States
Posted
Sep 29, 2020
Ref
R1530084
Required Education
High School or equivalent
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Title:

Specialist, QA Documentation Control

Direct Manager:

Manager, QA Document Control

Division:

CTDO Quality Assurance

Grade:

D04

Direct Reports:

N/A

Location:

Summit West, S-12

About Bristol-Myers Squibb

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.

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.
  • 3+ years of related Quality experience in the pharmaceutical or related industry
  • An equivalent combination of education and experience may substitute


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 8am to 4pm, Monday through Friday. 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.

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BMSCART

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.