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.
Scope of Position:
The Specialist will audit and evaluate the level of compliance of all site departments towards applicable Standard Operating Procedures (SOPs) and various health authority regulation, and serves as the leader of the internal auditing program for the site as managed within Compliance and Quality Operations The Specialist works with a broad scope of review and analysis of the site's quality system with the intent to identify areas of deficiency (operational non-compliance) and to identify continuous improvement opportunities. The Specialist, serving as an internal auditor, provides an overall assessment of operational compliance with the associated SOPs and policies.
Duties and Responsibilities:
• Internal Audit Program
• Assists with planning, scheduling, and maintaining the internal audit program at the site, with the approval of this individual’s management.
• Establishing and adhering to the internal audit schedule on an annual basis.
• Documents and reports on findings, recommendations and agreed-upon corrective actions.
• Participates in external audits and inspections.
• Preparing and submitting reports and providing information by required deadlines.
• The review of the previous audit report, work papers and implementation status of the findings and recommendations.
• Assists in presentation of findings and report preparation.
• Training other Compliance Specialists on general cGMP Quality System regulations and international standards.
• Training other Compliance Specialists on proper standards and practices of effective auditing.
• Conduct follow-up audits when necessary to non-compliance issues.
• Pre Audit planning and preparations
• Discussions with site management, departmental management, and departmental personnel involved in the specific areas of their assignments.
• Development of the audit scope and focus plus assignment of audit team responsibilities during the audit.
• Recommends and reaches agreement on corrective actions.
• Performs all other tasks as assigned
Knowledge, Skills, and Abilities:
• Demonstrates proficiency in applying audit principles, skills and techniques.
• Intermediate knowledge of cGMP regulations. Familiarity with ICH quality structure a plus.
• Intermediate knowledge of PC based office computers and standard Microsoft Office applications.
• Basic knowledge of electronic document and data management systems.
• Ability to demonstrate controlled gowning.
Education and Experience
• Bachelor’s degree required.
• 4 years’ relevant work experience required.
• ASQ Certified Quality Auditor (CQA) or equivalent certification required.
• 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.
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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.