DI/QC & Admin Lead

Job Information Employer: Auris Health, Inc. Job Title: DI/QC & Admin Lead Job Code: A011.9648 Location: Santa Clara, CA Job Type: Full-Time Rate of Pay: $150,000 - $170,000 All Job Posting Locations: Santa Clara, California, United States of America Job Function: Quality Job Sub Function: Quality Control Job Category: Professional Job Duties Work within the animal facilities of J&J MedTech Santa Clara locations supporting execution of preclinical studies required to competitively position robotic and digital solutions for regulatory approval and clinical acceptance. Conduct data review and inspection against procedures that apply to an FDA compliant 21 CFR Part 58 laboratory to ensure they are capable of supporting J&J Medical Devices. Implement Quality Control processes and procedures spanning from implementing quality standards through developing internal processes to optimize the quality control function in support of compliance under 21 CFR 58. Perform and oversee staff responsible for quality checks of study documentation, to identify quality issues through data integrity review of study files and other documents. Support development of corrective actions plans and work with cross‑functional teams related to the Good Laboratory Practices (GLP) program to implement new quality control procedures. Monitor, track, and trend deviations, and identify areas/processes that need correction or improvement, such as systemic issues and repetitive deviation. Ensure equipment has adequate maintenance, calibrations, and qualification within the testing and animal care facilities. Oversee archive including electronic, physical, wet tissues, test article retains, and test articles dispensary. Perform internal system inspections against established policies and procedures, including electronic system usage. Serve as Subject Matter Expert on 21 CFR Part 58 and provide compliance oversight for the Preclinical Research staff in the conduct of GLP. Perform in‑process and internal inspections against established policies and procedures for monitoring of animal husbandry, surgical lab execution, equipment usage, and user training. Review training files to ensure staff training curriculum is established and up to date. Direct process improvements, and develop/implement continuous quality improvement. Responsible for resourcing of lab activities and facility utilization. Manage purchase orders, vendors, inventory tracking, and specimens and supplies orders. May telecommute per company's policies (hybrid). Requirements Employer will accept a Master's degree in Biotechnology or related field and 2 years of experience in the job offered or in a DI/QC & Admin Lead–related occupation. EEO Statement Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Benefits Vacation – 120 hours per calendar year Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year Holiday pay, including Floating Holidays – 13 days per calendar year Work, Personal and Family Time – up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year Medicare, dental, vision and other benefits as provided in the applicable collective bargaining agreement Long‑term incentive program eligibility Retirement plan: pension and savings plan (401(k)) #J-18808-Ljbffr Johnson & Johnson