Bristol Myers Squibb Company

QA Document Control Associate Specialist

Location
Bothell, WA, United States
Posted
Sep 04, 2020
Ref
R1529231
Required Education
Bachelors Degree
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.

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:

The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Juno Manufacturing Plant (JuMP), including the document change control process, issuance and reconciliation of batch records, labels and batch related forms, and management of archival and retention of GMP records

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education:

Bachelor's degree or equivalent

Experience

Basic Qualifications:
  • Minimum of 5 years of relevant document control management experience in a cGMP/FDA regulated environment
  • Must have a strong technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles
  • Innovative, proactive, and resourceful; committed to quality and continuous improvement
  • Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables
  • Able to successfully manage multiple priorities
  • Strong project planning skills.
  • Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
  • Experience interacting with FDA or other regulatory agencies strongly preferred
  • Strong knowledge of cGMPs and domestic regulatory requirements
  • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)
  • Must complete tasks independently, notify supervisor of decisions outside of established processes and the ability to build an internal network.


DUTIES AND RESPONSIBILITIES:

Primary responsibilities include:
  • Issuing production batch records to support manufacturing operations
  • Maintain the GMP document storage room, the organization of associated document files and ensure that records are readily retrievable
  • Managing an electronic document system which includes creating and approving document change requests, formatting documents, managing document workflows through the appropriate lifecycle and releasing documents to an effective state
  • Writing and maintaining document control procedures and participating in the development and roll-out of document control tools
  • Follow Policies, SOPs and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests
  • Training and cross-training of Document Control personnel and customers to ensure adherence with procedures
  • Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site
  • Support internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during the audit. Assist with document retrieval /organization support during regulatory inspections
  • Perform Document Control metric reporting and analysis for the local site data. This may require the use of relational databases and reporting tools to collate and analyze quality data
  • Provide communication as to the status of Quality Systems deliverables to customers, management and stakeholders


WORKING CONDITIONS (US Only):

Employees holding this position will be required to perform job-related duties supporting the Manufacturing Operations, related to batch documentation to support the various Manufacturing shifts. Weekend and off-shirt support may be required.

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.