Specialist, Global Quality Systems

Employer
Celgene
Location
Summit, NJ, US
Posted
Oct 11, 2018
Ref
1803565
Required Education
High School or equivalent
Position Type
Full time
Other Locations:US- NJ- Summit West

Description

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.

Specialist, Global Quality Systems Documentation
Summit, NJ

Manager

Associate Director, Global Quality Systems Documentation

PURPOSE AND SCOPE OF POSITION

This position is responsible for supporting the Global Quality Systems Documentation group by coordinating activities related to GMP/GDP documentation systems, and administrating associated SOPs and business processes that ensure compliance with established company/industry requirements

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
  • Must have experience with cGMP manufacturing, Quality, and compliance;
  • Routinely recognizes and addresses quality opportunities to improve overall process/project efficiencies
  • Comfortable providing input within the department and across the organization
  • Able to write and review technical reports with clarity and brevity;
  • Provides guidance to other employees in technical writing skills
  • Good understanding of software development Life Cycle (SDLC) and electronic document management systems
  • Good understanding of records management systems and retention policies
  • Completes routine tasks with little or no supervision.
  • Requires moderate direction to complete more complex tasks
  • Recognizes risk for assigned project/processes and mitigates accordingly
  • 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


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;
  • Maintains training material for applicable document management systems
  • Provides end-user training on electronic document management systems
  • 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;
  • Serves as a business reviewer for GMP access requests
  • 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;
  • Support the archiving, retrieval and reconciliation of physical records
  • 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.
  • Performs other tasks as assigned


EDUCATION AND EXPERIENCE
  • HS diploma or equivalent required. College or university degree preferred.
  • Minimum of 3 years experience in the pharmaceutical or related industry
  • An equivalent combination of education and experience may substitute


Celgene 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.