Specialist Documentation Control

Profile

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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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