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Sr .Specialist QA Deviation Investigator

Employer
Celgene
Location
Bothell, Washington, United States
Start date
Oct 11, 2019

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Discipline
Quality, Quality Assurance
Required Education
Bachelors Degree
Position Type
Full time
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Job Details

Req #: 1902020
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

We are seeking a Sr. Specialist, Quality Deviation Investigator . This role is responsible for leading deviation investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the manufacturing and laboratory deviations. This position will lead root cause analysis sessions with site SME's and determine the associated corrective action to prevent the deviation from recurring. This person will be a key player in the JuMP Quality Assurance team and a champion for quality priority principles and compliance within the JuMP organization. This position reports directly to the Quality Manager responsible for deviation investigation management.
Job Responsibilities
  • Responsible for the Quality Assurance GMP deviation investigation lead at JuMP, and ensuring adherence to applicable GMP regulations and Juno policies and procedures
  • Provide consistent direction and ensure timely completion of deviation investigations to ensure on-going consistency for investigation reports that will stand alone during regulatory inspections.
  • Develop a comprehensive understanding of the manufacturing processes followed for Juno products and the associated risk management control strategy developed to identify process risks and associated critical controls around the associate processing steps.
  • Develop the necessary skills using the appropriate tool(s) and statistical application in risk management and Root Cause Analysis to enable the effective and timely close of deviation investigations.
  • Provide consistent oversight and recommendation of quality product disposition according to the results of the investigation.
  • Collaborate with stakeholders and management, and communicate investigation status to management as appropriate.
  • Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of implemented GMP policies and quality management systems.
  • Contribute to the development and execution of Juno's PLI and commercialization readiness plan at JuMP
  • Develop individual goals and ensure the timely completion of all deliverables.
  • Champion and foster a positive and successful collaborative quality culture, aligned with Juno's existing culture.
  • Act as subject matter expert for QA oversight of GMP deviation investigations during regulatory inspections.
Basic Qualifications and Education Requirements
  • BS in relevant Science or Engineering discipline and 7+ years of experience in execution of deviation investigations.
  • Experience in Quality Assurance function or technical Manufacturing Science and Technology (MSAT) role in a GMP manufacturing operation.
  • GMP compliance and FDA/EMA regulations experience
Preferred Qualifications
MS Degree in Science or Engineering
  • Background in Protein Biologics or Cell Therapy Manufacturing is required
  • Demonstrated excellence in written and verbal communication
  • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
THINK BIG. BE BRAVE. DELIVER

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.

Company

At Celgene Corporation, 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. As a global leader in biotechnology and CAR T cell therapy, Celgene is a place where employees can make a real impact on the lives of patients with unmet medical needs in cancer and inflammatory diseases.

As we rapidly advance our next wave of innovative medicines, we announce the creation of a new global Clinical Development Organization to accelerate and optimize clinical development across our entire mid- to late-stage portfolio. Our commitments in this area will further establish the function as a center of excellence and enhance our strategic leadership in discovery, development and commercialization.

Recognized by Forbes in 2018 as a Top 10 World’s Best Employer and by Business Insider as the #3 Most Reputable Pharma Company in the World, Celgene offers a unique work environment where you can help build the business, while building your career in ways you may not have thought possible. We’re looking for innovative self-starters who want to improve the lives of patients worldwide. For more information, visit https://www.celgene.com/careers/.

Company info
Website
Phone
908-673-9000
Location
Corporate Headquarters
86 Morris Avenue
Summit
New Jersey
07901
US

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