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Description
About Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 60 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology and hematology. If youd like to join a company where you can make a difference, please consider the Celgene family.
Prerequisites
BS or MS in analytical science or in a pharmaceutical related field. Minimum of five years experience in a QA/QC function within a Pharmaceutical company. Minimum of two years experience conducting/approving customer complaint, laboratory and non-laboratory investigations. Experience with tracking and trending investigations and CAPAs is required. Familiarity with Pilgrim, EtQ Reliance or other electronic system for managing investigations and CAPAs a plus.
Summary
Responsibilities include, but are not limited to, the following:
1) Celgene Customer Complaint Function: Reviews, tracks and trends global customer complaints. Ensures that applicable documentation and complaint investigation is completed in accordance with site customer complaint and investigation procedures. Tracks customer complaints to ensure completion according to established timelines. Trends global customer complaints and reports metrics to management. Provides oversight of the electronic Customer Complaint module.
2) Celgene Laboratory and Non-Laboratory Investigations: Reviews investigations and collaborates with the investigator to ensure that investigations are in conformance with established SOPs, and are clearly written and complete. This includes investigations from contractors/vendors. Provides decisions on investigation classifications (root cause analysis) in accordance with Celgene procedures. Tracks and reports on status of investigations and to ensure completion according to established timelines. Trends investigations reports and provides metrics to management.
3) Celgene CAPA: Tracks and reports on status of open CAPAs to ensure completion according to established timelines. Evaluates CAPA actions to ensure they address the assignable cause. Evaluates CAPA evidence before closing the CAPA action plan. This includes CAPA from contractors/venors. Trends CAPAs and reports metrics to management.
4) Compliance Systems: Develops, implements and maintains the activities of the Customer Complaints, Investigation and CAPA function in compliance with cGMPs, SOPs, good documentation practices and safety standards in accordance with corporate, regulatory and timeline expectations.
5) Vendor Contacts: Communicates, when necessary, with outsourced manufacturing and analytical service providers regarding deviations and investigations conducted at the vendor site. Tracks and trends customer complaints and investigations from vendors.
6) Communications: Maintains productive communications with internal colleagues in Quality Control, Quality Assurance, AR&D, Technical Operations, Drug Safety, Regulatory Affairs and senior management as needed to ensure timely completion of Customer Complaints, Investigations and CAPAs.
7) Human Resources: Diagnoses and defines work team needs for effective performance. Supervises the activities of at least one staff member. Ensures cross-training on the Investigations/CAPA systems.
Skills/Knowledge Required:
? BS/MS in the Sciences or Pharmaceutical related field
? 5+ years experience within QA/QC function in pharmaceutical industry
? 2+ years experience conducting customer complaint, laboratory and non-laboratory
investigations in the pharmaceutical industry
? Thorough knowledge of cGMP in the pharmaceutical industry
? Knowledge and application experience with investigation and root cause analysis tools and
methodology
? Good computer skills and working knowledge of common business software
? Excellent organizational skills
? Excellent problem-solving, verbal and written communication skills
? Must have strong interpersonal and communication skills, be a team player
? Must be an individual with proven initiative and demonstrated accountability
Equal Employment Opportunity
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.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employees temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the at-will employment relationship between the employee and Celgene.
Details:
Job Id:
18651579
Posted / Updated:
4/7/2010 3:40:29 AM
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