Organization : Quality Operations
Employee Status :
Job Type : Fixed Term
Associate Specialist, QA Compliance
Sr Specialist, QA Compliance
BS in Science or related field.
QA Compliance is committed to actively support Celgene Boudry and Couvet manufacturing sites and other departments to ensure cGMP compliant processes on both sites.
This position is responsible for quality assurance (QA) involved primarily with the support of the different quality system tools in place to ensure cGMP compliance throughout the Boudry and Couvet manufacturing sites.
The position holder will be responsible for the assigned processes and activities within QA Compliance team.
The activities include responsibility for execution of the main following processes : internal audits, annual product review reporting, product quality complaints and supplier’s qualification.
Additional tasks are the support of health authorities inspections and corporate audits, monitoring of regulatory changes, response to regulatory authorities requests, QA oversight on contract manufacturing / testing partners, reporting of quality processes metrics, deployment and execution of annual GMP training.
The QA Compliance Associate Specialist can be assigned special tasks in cross-functional projects to support Boudry and Couvet manufacturing sites activities like introduction of new product on the manufacturing site.
As a member of the Quality Operations department, this position will be working closely with the QA Compliance management to identify and handle process quality and cGMP compliance related issues.
Skills / Knowledge Required
Duties and Responsibilities
Supports internal audits plan by executing self inspections and following-up on action plans.
Supports the supplier qualification process by assisting in material supplier and vendor evaluation and approval. Provides support for vendor and supplier contract setup and modification, as needed.
Is responsible to handle deviations, CAPA and change controls related to suppliers.
Generates annual product reports for products made on Boudry and Couvet manufacturing site.
Supports the product quality complaints process by handling complaints and executing investigations as assigned.
Supports preparation and execution of authorities inspections and corporate audits in different roles (i.e. back office, subject matter expert, note taker or runner) for Boudry and Couvet Sites.
Contributes of regular reporting of quality processes metrics for different review meetings
Ensures the representation of QA within department and cross-functional project teams according to assignments.
Assists with writing SOPs and makes recommendations for SOP revisions for the Quality Operations and supported departments of Boudry and Couvet manufacturing sites.
Acts as deputy for colleagues within QA Compliance team.
Can be assigned ownership of QA Compliance processes, including coordination of day to day activity, maintenance of associated documentation, participation of process enhancement and training of new users.
Definitions and Abbreviations
CAPA : Corrective and Preventive Action
cGMP : Current Good Manufacturing Practices
QA : Quality Assurance
QC : Quality Control
SOP : Standard Operating Procedure
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.