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Job Details


Bristol-Meyers Squibb, Co.

Process Improvement Lead, QA Document Control (R1559380-en-us)

Pharmaceuticals

All

Yearly

No

Bothell, Washington, United States

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.

The Process Improvement Lead supports the cGMP operations at the BMS Jump site. The incumbent will primarily be responsible for managing complex document management projects in addition to developing and implementing process improvements for the Jump document management process

This role will also be responsible for authoring, planning, developing, editing, and facilitating the approval of high-quality site cGxP documents.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education:

Bachelor’s degree or equivalent. Previous work experience is acceptable.

Experience

Basic Qualifications:

  • Strong project management skills and possess the ability to manage multiple priorities is required.
  • Minimum of 5 years of relevant Quality experience in a cGMP/FDA regulated environment
  • Must have a strong technical writing and verbal communication skill set.
  • Proven ability to critically review documents while effectively inputting and expressing Quality principles
  • Innovative, proactive, and resourceful; committed to quality and continuous improvement
  • Ability to learn and understand complex topics
  • Strong ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables
  • 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 cGxPs and domestic regulatory documentation requirements
  • Knowledge of manufacturing quality (QC, manufacturing, facilities, critical systems, validation, etc.)
  • Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network.

DUTIES AND RESPONSIBILITIES:

Primary responsibilities include:

  • Evaluate site current procedural documents and develop innovative approaches for improvement
  • Developing comprehensive, clear, easy to follow procedural documentation that meets all regulatory and internal standards.
  • Work across internal teams to support the development of high-quality cGxP documentation
  • Developing detailed tools and resources for developing clear instructional documents such as job-aides, reference guides, etc.
  • Facilitate document changes including the editing, review, and approval of site documents using the electronic Document Management System including assigning effective dates and training workflows, and archive documents and document change requests
  • Provide status updates of Quality Systems deliverables to customers, management and stakeholders
  • 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 and develop document management metric reporting and analysis for local site data. This may require the use of relational databases and reporting tools to collate and analyze quality data
  • Support internal and external audits and regulatory inspections. This may require scanning, and document retrieval /organization during regulatory inspections
  • Perform Document Control metric reporting and analysis for the local site data relative to records management. This may require the use of relational databases and reporting tools to collate and analyze quality data

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-shift 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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.