Req #: 1902829
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
Purpose and Scope of Position
The Specialist, QA eSystems' primary responsibility is to help assure the quality, integrity, and compliance of site Information Technology (IT) systems, and maintain alignment between business process owners, end users, and other cross functional areas. Altogether, the Specialist will help ensure that IT systems are designed, setup, and function in a GMP-compliant manner which, in turn, will assist the site in safeguarding and maintaining the safety and quality of Celgene's products.
Required Competencies: Knowledge, Skills, and Abilities
Intermediate knowledge of GMP guidance and regulations, including those pertaining to computerized system design, function, and use.
Intermediate knowledge of Microsoft Word, Outlook, and Excel.
Requires ability to communicate appropriately with regulatory agencies
Intermediate written and verbal communication skills.
Intermediate problem-solving, critical-reasoning, and decision-making skills.
Intermediate time-management, organizational, and multi-tasking abilities.
Duties and Responsibilities
Maintain the quality, integrity, and compliance of company IT systems in order to help assure the safety and quality of Celgene products.
Provides input and quality approvals for validation documentation that supports enterprise systems or applicable site owned systems.
Provides quality approvals for audit trails related to batch release and periodic review
Drives use of best-practices during IT systems design, validation, and use.
Collaborates with business stakeholders, technical support groups and Quality Assurance (as needed) to thoroughly investigate validation or engineering discrepancies.
Ensures all required system documentation is maintained as changes in the system(s) are made. Documentation includes but not limited to functional requirements, user requirements, and design specifications.
Reviews and approves documents, change controls, and protocols related to IT systems.
Supports deviations as needed.
Represents and leads Phoenix Quality Operations through the initiation and implementation of projects related to electronic systems.
Manages project activities and ensures appropriate team members are assigned to appropriate activities.
Supports continual alignment of the business process with other business functions and provide effective on-going end user support.
Develops, maintains and improves key business processes.
Drafts, reviews, and edits SOPs, process flow and other business documentation.
Performs all other tasks as assigned.
Education and Experience
Bachelor's degree preferred, preferably in Science or Engineering.
4 years' relevant work experience required from within a regulated pharmaceutical environment.
Experience working in Quality and/or Manufacturing is required.
Strong knowledge in Computer Systems Validation (CSV) is required.
An equivalent combination of education, experience and training may substitute.
Definitions and Abbreviations
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.