Skip to main content

This job has expired

You will need to login before you can apply for a job.

Associate Specialist, QA Compliance

Employer
Celgene
Location
Phoenix, Arizona, United States
Start date
Jan 16, 2019

View more

Job Details

Req #: 1804529
Location: Phoenix, Arizona, United States
Job Category: Quality
Work Location: 620 N. 51st Avenue 85043
Organization: Quality Operations
Employee Status: Full-time
Job Type: Regular

ASSOCIATE SPECIALIST, QA COMPLIANCE
Phoenix, AZ

Purpose and Scope of Position:
The Associate Specialist, Compliance will audit and evaluate the level of compliance of site
departments towards applicable Standard Operating Procedures (SOPs) and various health
authority regulation. The Associate Specialist works with a broad scope of review and analysis of
the site's quality system with the intent to identify areas of deficiency (operational non-compliance)
and to identify continuous improvement opportunities. The Auditor, serving as an internal auditor,
assists with individual assessments of operational compliance with the associated SOPs and
policies.

Required Competencies: Knowledge, Skills, and Abilities:
  • Basic knowledge of cGMP regulations. Familiarity with ICH quality structure a plus.
  • Demonstrates ability in applying audit principles, skills and techniques.
  • Basic knowledge of PC based office computers and standard Microsoft Office applications.
  • Basic knowledge of electronic document and data management systems.
  • Ability to demonstrate controlled gowning.

Duties and Responsibilities:
General Compliance and Inspection
  • Participate in development of annual internal audit schedule.
  • Monitors, tracks, and communicates status of observation responses and pending correctives actions.
  • Creation of reports that support department and site metrics related to compliance and inspection.

Audit Preparation and Performance
  • Development of the audit scope and focus plus assignment of audit team responsibilities during the audit.
  • Schedules opening and closing meetings with impacted departments.
  • Reviews the previous audit report, impacted document, change controls, and deviations related to scope of planned audit.
  • Execute audits against approved audit job aids and checklists, relevant SOPs, and relevant regulatory requirements.
  • Calibrate audit findings and observations with senior team member and management.
  • Generation of final audit reports including observation, finding, and related regulatory references.
  • Assisting with 3rd party audits and inspections as needed.
  • Perform room set ups prior to inspections start.
  • Participate as needed to support business need during inspections.
  • Facilitate and fill pre-audit documentation requests.
  • Track, monitor, and support requests during inspections.

Performs all other tasks as assigned.

Education and Experience:
  • High school diploma or equivalent required.
  • Bachelor's degree preferred.
  • 3 years' relevant work experience required.
  • ASQ Certified Quality Auditor (CQA) certification preferred.
  • An equivalent combination of education and experience may substitute.

Working Conditions:
Work is performed in a typical office environment, with standard office equipment available and
used. Work is generally performed seated, but may require standing and walking for up to 10% of
the time. Lighting and temperature are adequate and there are no abnormal conditions caused by
noise, dust, etc.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

#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.

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

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert