Contract-Quality Assurance Support

Xencor • Pasadena, CA

18h • $36 - $46 • Hybrid

About The Position

Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb® bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit www.xencor.com. We have an excellent opportunity for a Contractor Quality Assurance Support to join our team.
This contract position will be a hybrid position with 2 days a week onsite in our Pasadena site.
Responsible for supporting, on a contract basis, them with development, implementation, and maintenance of Quality Assurance systems and activities.

Requirements

• High School diploma/GED and 6 years of quality systems and operations experience within a regulated industry or other equivalent combination.
• Experience working with document control processes and current industry practices required.
• Knowledge of computer software, including relevant applications such as MS Word, Excel, and PowerPoint
• Familiarity with relevant laws, legal codes, government regulations and agency rules
• Working knowledge of GxP regulations and guidance’s
• Excellent interpersonal, verbal and written communication skills
• Attention to detail, organizational skills, ability to multitask and follow tasks through to completion.
• Ability to work independently and in a team environment
• Analytical and problem-solving skills
• Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model

Nice To Haves

• A Bachelor’s degree in science and a minimum of 2 years of previously referenced experience is preferred.
• Experience in internal auditing as well as working with regulatory agencies preferred.

Responsibilities

• Supports QA documentation and record keeping
• Independently reviews QA documents within area of responsibility
• Manages and performs QA review of assigned deviations, CAPAs, and change controls.
• Assists process managers with drafting and revising SOP’s and forms
• Adheres to all department and company-wide policies regarding conduct, performance and procedures
• Attends both internal and external cross-functional meetings as needed
• Performs other duties as assigned
• Processes external vendor quality records in the eQMS, including record creation, routing, assignment, and tracking
• Assists with QA oversight of GMP contract organizations, such as CMO/CDMOs, CTO, and 3PLs
• May interface with vendors on quality matters
• Assists with QA product release activities in accordance with Xencor standard operating procedure
• Assists with the creation, review, approval, distribution, revision and archiving on GXP documents in EDMS
• Assists with EDMS access control and security
• Ensures documents meet Good Documentation Practices
• Assists with the onboarding and offboarding of GXP staff
• Assists with the training documentation and Learning Management System (LMS)
• Ensures compliance with applicable regulatory requirements
• Assists with the change control, deviation, CAPA and internal audit programs supporting effective issue resolution and continuous improvement
• Assists with the development, monitoring and improvement of the Quality Management System metrics and reporting processes

Benefits

• The Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws.

What This Job Offers

• Career Level: Mid Level
• Education Level: High school or GED