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.
Purpose and Scope of Position
The Quality E- Systems Senior Specialist’s 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 Senior 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
- Advanced knowledge of GMP guidance and regulations, including those pertaining to computerized system design, function, and use.
- Advanced knowledge of electronic batch records, 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.
- Ability to work independently for extended periods of time
- Ability to interpret / write technical documents.
- Ability to solve routine and complex problems.
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 and/or globally 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.
- Coordinate with IT and other site departments to maintain and support electronic systems that are compliant, efficient, effective and reliable.
- 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 (site and global).
- Applies data integrity regulations and guidance from governing agencies when participating in site and global projects related to computerized systems.
- Supports deviations as needed.
- Represents and leads Quality Assurance Operations for CAR T 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.
- Provide training to appropriate end users as related to enterprise system implementation and updates.
- 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.
- 5 years’ relevant work experience required in the pharmaceuticals or related industry.
- 2 years of experience supporting electronic quality systems.
- An equivalent combination of education, experience and training may substitute.
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.
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.