IT Manufacturing Compliance Specialist

Celgene Corporation Bothell , WA 98021

Posted 5 days ago

Job Description: Req #: 1900944

Location: Bothell, Washington, United States

Job Category: Information Technology

Work Location: 1522 217th Pl SE 98021

Organization: Information Technology

Employee Status: Full-time

Job Type: Regular

In this role, you will be responsible for ensuring quality and promoting efficiency of Manufacturing Execution System projects at Juno. You will work to maximize the utility of the system, including definition of business processes, user engagement and training, as well as document administration activities. You will also occasionally be called upon to support software release activities, providing coordination around complex projects, while balancing business priorities. You will support projects at Juno's current multi-product clinical facility in Bothell, WA with potential to support future manufacturing capacity in additional locations.

Primary Responsibilities:

  • Acts as owner for Manufacturing Systems documentation and release coordination.

  • Authors SOPs, work instructions and training materials defining MES change management process and Software Development Lifecycle (SDLC)

  • Creates/approves role-based system training for user groups

  • Assists with refinement and definition of user and system requirements during upgrades or changes

  • Improves business processes for system documentation/Software development lifecycle

  • Cross trains to perform other roles within IT Manufacturing Systems department

Required Experience/Education:

  • Bachelor's degree or equivalent in work experience.

  • 3-5+ years relevant industry experience

  • Strong communication and collaboration skills.

  • Experience working within electronic document management systems/quality management systems for regulated industries

  • Excellent written and verbal skills, ability to clearly organize written requirements is essential

Preferred Experience and

Skills:
  • Knowledge of cGMP regulations and FDA guidance applicable to computerized systems, electronic records and signatures.

  • Experience acting as release analyst, project coordinator or document specialist preferred.

  • Some Manufacturing Systems experience is preferred

  • Proven ability to understand business goals and recommend new approaches to effect continual improvements in business objectives.

  • The ability to manage multiple priorities simultaneously, have a strong drive - orientated on results

  • Strong analytical skills and ability to provide data based insights and observations

  • Being an enthusiastic team player with a strong drive to create a positive and fun work environment

  • Passion for innovative and process improvement

  • Detail oriented with excellent verbal and written communication skills

  • Desire to grow and take on increased scope of responsibility

#LI-POST

About Us

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.


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IT Manufacturing Compliance Specialist

Celgene Corporation