Associate Manager, Quality Assurance Job

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Date: May 20, 2014 Location: Berkeley Heights, New Jersey, United States 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) Additional responsibilities: 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. *LI-KM1 Qualifications  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 Schedule: Regular Shift: Standard 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
Phama Job Categories: 
Clinical research and pharmacovigilance

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