QA Specialist Inspection Readiness

Employer
Celgene
Location
Bothell, Washington, United States
Posted
Jun 17, 2019
Ref
1804640
Required Education
Bachelors Degree
Position Type
Full time
Req #: 1804640
Location: Bothell, Washington, United States
Job Category: Quality
Work Location: 1522 217th Pl SE 98021
Organization: Quality Operations
Employee Status: Full-time
Job Type: Regular

QA Specialist, Inspection Readiness
Bothell, Washington

Job Description:
At Juno Manufacturing Plant (JuMP), a Celgene Corporation company, we're committed to changing the course of human health through bold pursuits in science, life-enhancing therapies and a promise to always put patients first. At the core of that mission are the talented individuals on our Quality Operations team who collaborate globally and cross-functionally to drive innovation.

Join our team as a QA Specialist, Inspection Readiness and help us deliver truly innovative and life-changing medications to our patients worldwide.

What great looks like in this Role:

Our ideal QA Specialist is responsible for coordinating pre- and post-inspection activities, including training, functional area readiness and storyboards. Scheduling and conducting mock interviews for subject matter experts (SMEs) and providing guidance to functional representatives before, during and after audits. If you're up for the challenge, apply today!

Responsibilities of this Role:
  • Track action items resulting from audit / inspection observations and drive through to completion
  • Coordinate the self-inspection program including coordination of self-inspection audits, annual planning of audit events, maintaining related SOPs and training of self-inspectors
  • Monitor inspections and provide support, as appropriate
  • Review and facilitate responses to audit reports
  • Distribute inspection data trends to the Quality Unit for management review
  • Review, analyze and distribute regulatory inspection data issued by regulatory authorities (FDA, EMA, PDMA) to ensure proactive compliance across the organization
  • Communicate an inspection preparation plan for the site
  • Develop storyboards, along with functional areas and subject matter experts (SMEs) to be shared during audits for key processes and programs

Knowledge and Skills Required:
Basic Qualifications:
  • BS Degree in Life Sciences
  • 5+ years of experience in a regulated environment
  • Experience interacting with FDA or other regulatory agencies (e.g. EMA, PDMA)
Preferred Qualifications:
  • Familiar with all phases of biologic and small molecule drug development
  • Promote an environment of accountability, diversity and speaking up
  • Ability to analyze, balance, and prioritize daily activities
  • Experience with GCP/GLP/GMP auditing practices
  • Strong knowledge of federal regulations and other applicable standards
  • Must have strong project management experience with a track record of meeting goals and objectives
  • Must have a strong technical writing skill set and be able to critically review reports
About Us

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.

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.