Quality Assurance Specialist II

Regulatory Affairs & QA · San Diego, California
Department Regulatory Affairs & QA
Employment Type Full Time

 

Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego.  We have an excellent opportunity for a Quality Assurance Specialist II to join our team.  We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and are more potent, safer and longer lasting – to improve patient outcomes and quality of life.  In addition to generating a pipeline of novel drug candidates, with eight in clinical testing by Xencor or our partners, our XmAb® technology has been validated through our collaborative agreements with leading biopharmaceutical companies including Novartis, Amgen,  Morphosys, Merck, CSL, Janssen(J&J), Alexion, Gilead 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:

  • Assures GxP compliance of the QC laboratory systems and controls
  • Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. 
  • Provide Document Control support for GMP Quality systems
  • Provide support for the Learning Management System (LMS) 
  • Issues control GMP forms 
  • QA Review and approval of QMS SOPs
  • As required, performs QA review and approval for internal change controls, deviations, CAPAs and documentation changes
  • Maintains current knowledge of industry standards as it applies to cGMPs, GLPs and global regulatory guidelines and requirements
  • 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.

Requirements/Qualifications:

  • 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 GMP Document Control processes
  • 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

Physical Demands:

The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

The physical demands of the office are normally association with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Work is performed in an office environment.

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 to recruiting@xencor.com. For further information about Xencor, please visit our website at www.xencor.com.

Xencor does not accept profiles or resumes from recruiting vendors without a prior, binding written agreement.

Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor, implied or otherwise.

 

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  • Location
    San Diego, California
  • Department
    Regulatory Affairs & QA
  • Employment Type
    Full Time