Contract-Quality Assurance Support

Introduction: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 . We have an excellent opportunity for a Contractor Quality Assurance Support to join our contract position will be a hybrid position with 2 days a week onsite in our Pasadena : Responsible for supporting on a contract basis them with development implementation and maintenance of Quality Assurance systems and Duties:Supports QA documentation and record keepingIndependently reviews QA documents within area of responsibilityManages and performs QA review of assigned deviations CAPAs and change process managers with drafting and revising SOPs and formsAdheres to all department and company-wide policies regarding conduct performance and proceduresAttends both internal and external cross-functional meetings as neededPerforms other duties as assignedIn addition to the responsibilities above incumbents in this position will be assigned additional tasks below based on the department groups they are : External QA/Vendor OversightProcesses external vendor quality records in the eQMS including record creation routing assignment and trackingAssists with QA oversight of GMP contract organizations such as CMO/CDMOs CTO and 3PLsMay interface with vendors on quality mattersAssists with QA product release activities in accordance with Xencor standard operating procedureGroup: Document ControlAssists with the creation review approval distribution revision and archiving on GXP documents in EDMSAssists with EDMS access control and securityEnsures documents meet Good Documentation PracticesGroup: GXP TrainingAssists with the onboarding and offboarding of GXP staffAssists with the training documentation and Learning Management System (LMS)Ensures compliance with applicable regulatory requirementsGroup: Quality Systems & ComplianceAssists with the change control deviation CAPA and internal audit programs supporting effective issue resolution and continuous improvementAssists with the development monitoring and improvement of the Quality Management System metrics and reporting processesEducation/Experience/Skills:Position minimally requires a High School diploma/GED and 6 years of quality systems and operations experience within a regulated industry or other equivalent combination. A Bachelors degree in science and a minimum of 2 years of previously referenced experience is preferred. Experience working with document control processes and current industry practices required. Experience in internal auditing as well as working with regulatory agencies also requires:Knowledge of computer software including relevant applications such as MS Word Excel and PowerPointFamiliarity with relevant laws legal codes government regulations and agency rulesWorking knowledge of GxP regulations and guidancesExcellent interpersonal verbal and written communication skillsAttention to detail organizational skills ability to multitask and follow tasks through to to work independently and in a team environmentAnalytical and problem-solving skillsAbility to demonstrate competencies applicable for job based on Xencors Leadership Competency ModelOccasional travel may be required including travel between Xencors Pasadena and San Diego offices. Expected Contract Hourly Rate Range: $36.00 to $45.50The actual salary will be based on the selected candidates qualifications including skills competencies education and with Disabilities Act (ADA) StatementThe 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. If you have a disability and require assistance in this application process please contact perform this job successfully an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential Employment Opportunity (EEO) StatementThe Company is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to age race color religion sex sexual orientation gender or gender identity national origin disability status protected veteran status or any other characteristic protected by state or federal does not accept profiles or resumes from recruiting vendors without a binding written agreement. Any unsolicited submission of