Specialist, Quality Systems
Other Locations:US- NJ- Warren
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, Quality SystemsWarren, NJ
PURPOSE AND SCOPE OF POSITION:
The Specialist is responsible for supporting the quality systems group from a Subject Matter Expert (SME) standpoint in accordance with Celgene policies, standards, procedures and Global cGMP. Functional responsibilities include coordinating the site's document control process, maintaining the vendor management and quality agreement program, GMP training, and participating in global quality systems projects.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Must have experience with cGMP manufacturing, Quality, and compliance.
- Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
- Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
- Must possess an independent mindset.
- Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
- Work is self-directed.
- Confident in making decisions for minor issues.
- Routinely recognizes Quality issues and solves problems.
- Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.
- Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
- Is recognized Subject Matter Expert within the group.
- Provides guidance to other employees in interpretation of complex data.
- Capable of providing input within the department and cross functional teams.
- Builds relationships internally within and with cross functional teams.
- Contributes to goals within the work group.
- 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 effectively multi-task and execute project management skills.
- Knowledge of US and global cGMP requirements.
- Excellent verbal and written communication skills.
DUTIES AND RESPONSIBILITIES
- Serve as the Administrator of the document control database system.
- Review and approve site procedures and documents within the document control system.
- Manage the periodic review program for site documents.
- Review and approval of executed batch records.
- Maintain the site vendor management program.
- Author and manage quality agreements with vendors.
- Manage and assign training curriculums for site personnel.
- Create and maintain training plans for departmental functions.
- Drive quality system harmonization with other sites and teams within Celgene.
EDUCATION AND EXPERIENCE (As Applicable)
- B.S. degree required, minimum of five years of experience in the pharmaceutical or related industry.
- Equivalent combination of education and experience acceptable
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.
DEFINITIONS AND ABBREVIATIONS (As Applicable)
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.