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Celgene Supervisor, QA Document Control in Bothell, Washington

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

The Document Control Supervisor is a full-time position with primary responsibilities of coordinating Document Control personnel and activities related to the identification, collection, distribution and filing of controlled documents. Key contributions include writing, revising and maintaining document control procedures and participation in the development and deployment of document control tools. This primary location for this position is at the Juno Manufacturing Plant (JuMP) located in Bothell, Washington.

The primary responsibility of this role is to provide direct supervision of Document Control team members and to promoting a team environment through training, mentoring, and motivating to achieve departmental daily requirements. The Document Control Supervisor will be to assist the QADC department in maintaining the Quality culture at JuMP by ensuring batch record issuance is completed on time to meet daily manufacturing processing schedules.

The supervisor schedules and plans work assignments for department and ensures other department support is maintained to achieve company and functional area goals and objectives. The Document Control Supervisor also ensures the release of documentation supporting manufacturing, and quality departments is current, accurate, and processed in a timely manner.

Primary responsibilities include:

  • Serves as primary point of contact for site functional areas regarding documentation and records; provides support and guidance to groups and subject matter experts (SMEs) for activities related to the development and maintenance of site documentation, procedures, work instructions, and templates.

  • Sets clear performance standards and holds team accountable for results; values, recognizes and rewards the achievement of others; promotes teamwork.

  • Maintain the document storage room through the organization of associated document files, archival of documents and records and ensure that records are readily retrievable.

  • Managing an electronic document system which includes creating and approving document change requests, 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.

  • Develops and delivers training regarding process or system changes. Trains on changes to systems-based tools that promote high quality documentation, efficient processes, and compliance with quality system requirements.

  • 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 routine and ad hoc 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.

  • Monitors documentation system function; investigates and coordinates with System Administrator on any issues.

  • Provide communication as to the status of deliverables to customers, management and stakeholders.

  • Act as Subject Matter Expert (SME) to support cross functional groups on root cause analysis and development of corresponding corrective and preventive actions.

  • Issuing production batch records to support manufacturing operations.

Required Qualifications

  • 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 activities and update priorities accordingly.

  • Strong project planning skills.

  • Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Veeva 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.)

Educational Requirements:

  • Bachelor’s degree from an accredited higher learning institution or higher in scientific field or equivalent in number of years of experience.

  • Experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA.

Our headquarters, situated in the bustling South Lake Union district of Seattle, sits among some of the most visible organizations in the world. Seattle offers award-winning restaurants, a vibrant, hip music scene and spectacular views of water and mountains. Within an hour’s drive of Seattle, you can be fishing, skiing, hiking or tasting world-class Washington wines.

THINK BIG. BE BRAVE. DELIVER.

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

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