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.
Responsible for Quality Assurance oversight of the analytical laboratory operations, Metrology, Stability services, and Validation for GMP commercial activities conducted at the NJ sight.
Manage is responsible for the following activities:
Review and approval of laboratory related GMP documents including, but not limited to:
1) SOPs, Work Practices and associated Forms
2) Validation plans, protocols and reports
3) IQ/OQ/PQ protocols and reports (equipment and software related)
4) User Requirements Specifications
5) Certificates of Analyses and Reference Standard Purity Statements
6) Analytical Protocols and Reports related to method validation, method transfer, deviations, method evaluations, etc.
7) Approval of analytical Methods and Specification documents
8) Quality Approval of Change Controls
9) Quality approval and oversight of all laboratory related Deviations, Investigations and CAPAs.
10) Provides QA oversight and approval of the annual equipment review
11) Approval of methods implemented by Contract Service Provides (CSPs)
1) Assures QA oversight meets or exceeds industry and FDA trends/expectations
2) Implements new policies/systems in keeping with constantly changing/emerging FDA/industry requirements.
3) Assists in the development of procedures based on regulations, industry guidelines and Celgene requirements
4) Supports HA inspections as needed
5) Evaluates lab investigations and if HA notification is required escalate to management
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.
BS/MS in pharmaceutical or related science with at least 8-10 years experience analytical laboratory and QA discipline
Thorough knowledge of cGMP in the pharmaceutical industry
Strong verbal and written communication skills
Ability to lead and work within a team setting
Req ID: 14001140
Primary Location: United States-New Jersey-Berkeley Heights
Job: Quality Ops
Organization: Celgene Corporation
Employee Status: Manager
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 5 % of the Time
Job Posting: 2014-04-21 00:00:00.0
Celgene is delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases.