Quality Assurance Associate II
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 five programs currently in clinical testing with three more expected to start clinical testing by 1H2019 and have an excellent opportunity for a Quality Assurance Associate II 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 eleven in clinical testing by Xencor or our partners, our XmAb® technology has enabled multiple collaborations with leading biopharmaceutical companies including Novartis, Amgen, Morphosys, 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.
The Quality Assurance (QA) department is seeking an experienced associate responsible for supporting the Quality Control (QC) Laboratory located at Xencor’s headquarter in Monrovia. CA. The position will focus on providing support for the bioanalytical laboratory in compliance with GMP and GLP regulations.
We seek a/an Quality Assurance Associate to:
Job Duties include:
- Assures GxP compliance of the QC laboratory systems and controls
- Performs timely QA review and approval of documentation for QC testing
- Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs
- As required, performs Quality Operations review and approval for internal change controls, deviations, CAPAs and documentation changes
- Reviews and approves method qualification/validation protocols, reports and trend data
- Maintains current knowledge of industry standards as it applies to cGMPs, GLPs and global regulatory guidelines and requirements.
- Identify user trends for system, procedure, and training improvements
- Support and enhance Inspection Readiness initiatives
- Performs supplemental investigations/projects as required by senior management
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.
- Quality Assurance Associate 2 or higher
- Bachelor's Degree in science or related field and 2+ years of demonstrated and effective quality systems and operations experience
- Knowledge of relevant laws, legal codes, government regulations and agency rules. Includes the understanding of ICH, GLP, cGMP requirements, GXP regulations and current industry practices.
- Comprehensive knowledge of change control management and Corrective Action/ Preventative Action (CAPA) quality management systems
- Knowledge of computer software, including relevant applications such as MS Word, Excel, and PowerPoint
- Excellent interpersonal, verbal and written communication skills
- Attention to detail, organizational skills, ability to multitask and follow tasks through to completion.
- Work independently and in a team environment
- Analytical and problem-solving skills
- Experience with immunoassay and bioassay analytical techniques in a GxP environment preferred.
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