Quality Auditor lll - QA Associate - Monrovia, CA | Biospace
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Quality Auditor lll - QA Associate

Xencor

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Location:
Monrovia, CA
Posted Date:
8/14/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Associate, QA, Quality, Quality Assurance,

Job Description


Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego.  We have a very deep drug development pipeline including three programs currently in clinical testing with one more expected to start clinical testing in 2017 and have an excellent opportunity for a QA Auditor lll / QA Associate to join our team.  We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and have the potential to be more potent, safer and longer lasting – with the goal of improving patient outcomes and quality of life.  In addition to generating a pipeline of novel drug candidates, with ten in clinical testing by Xencor or our partners, our XmAb® technology has enabled multiple collaborations with leading biopharmaceutical companies including Novartis, Amgen,  Morphosys, Merck, CSL, Janssen(J&J), Alexion and Boehringer Ingelheim.  

Our employees are the most important factor in our success and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.

Job Duties include:

•   Reports to Senior Director of Quality Assurance for External Compliance at Xencor.
•   Supports the Manufacturing Department at Xencor in its endeavor to manufacture and test Xencor investigational medicinal products (IMPs) under the FDA Good Manufacturing Practices (GMP) regulations and EU ICH Quality Guidances and EU Directives at various contract manufacturing organizations (CMOs).
•   Perform external GMP vendor audits of manufacturing facilities, testing facilities and critical raw material supply vendors.  Documents audit observations and makes recommendations for corrective action.
•   Support the Preclinical Development Department at Xencor in its toxicological and pharmacokinetic studies under the FDA Good Laboratory Practices regulations through external audits of vendors.
•   Perform GLP Facility audits in support of active, ongoing, Xencor GLP studies and/or clinical assay support.  Documents audit observations and makes recommendations for corrective action.
•   File audit reports and summaries on GMP/GLP/GCP studies.
•   Participate in or lead external audits of GMP/GLP facilities for Xencor.
•   Assist in Sponsor Review of executed CMO Batch Records for the manufacturing of various Xencor IMPs.
•   Interact effectively with other Xencor employees in a team setting.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Requirements


Qualifications/Requirements:

•   Bachelor’s Degree or equivalent in Biology/Chemistry or related field, with at least 2-5 years experience in Quality Assurance for the pharmaceutical industry in the GLPs and GMPs.  
•   Emphasis on the GMP.  
•   Experience at GLP/GCP audits a plus.  
•   Travel may be required for up to 20% of the time.

We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development.  With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package. Please submit a cover letter & resume.  For further information about Xencor, please visit our website at www.xencor.com   EOE