Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
1. PURPOSE AND SCOPE OF POSITION:
This position is responsible for supporting the Global Quality Systems Documentation group by coordinating activities related to electronic GMP/GDP documentation systems, and administrating associated SOPs and business processes that ensure compliance with established company/industry requirements
2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• Experience with cGMP manufacturing, Quality, and compliance;
• Routinely recognizes Quality opportunities and solutions
• Capable of providing input within the department and with cross functional teams
• Must demonstrate good technical writing skills and be able to follow technical reports;
• Basic understanding of SDLC and electronic document management systems
• Basic understanding of records management systems and retention policies
• Complete routine tasks with little or no supervision.
• Propose solutions for complex issues and work with management to resolve
• Understands the basics of continuous improvement and improves efficiency and productivity within the group or project.
• Comfortable providing training/guidance to system users as needed, and in instructor-led settings
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy
• Able to produce data reports with precision
• Must be time organized and self-directed;
• Experience supporting a global matrix organization
3. DUTIES AND RESPONSIBILITIES:
• Serve as a documentation system SME and provide guidance to system users as needed.
• Serve as a Document Control Reviewer/Approver on documentation managed through the electronic GMP/GDP documentation management system;
• Assists with maintenance and administration of procedures related to job function;
• Systematizes and streamlines document workflows;
• As needed, develops training material and trains system users
• Works independently and has a direct impact on documents that are subject to regulatory authority inspection;
• Compiles applicable process metrics, identifies trends and escalates accordingly.;
• Coordinates activities and projects with other functions, such as GMP Training;
• Ensures that documentation complies with established documentation system standards/requirements;
• Provides support during internal and health authority inspections of facilities and CSPs;
• Monitors the periodic review process for documents;
• Communicates effectively with all cross functional and regional stakeholders on matters related to documentation systems;
• Distributes official documents to internal and external customers as needed;
• Works with team to implement records management policies and schedules for the electronic and physical records as needed;
• Carries out plans and actions in the documentation system to support acquisitions, new product launches, product in-license operations, new market and trading partner opportunities, and other quality management activities as assigned.
• Supports Quality Systems harmonization efforts with Celgene sites globally.
4. EDUCATION AND EXPERIENCE:
• HS diploma or equivalent required. College or university degree preferred.
• Experience in the pharmaceutical or related industry
5. WORKING CONDITIONS: (US Only):
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-POSTCelgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.