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**Job Function: **
Quality
**Job Sub Function: **
Quality Control
Job Category:
Professional
All Job Posting Locations:
Santa Clara, California, United States of America
Job Description:
Employer: Auris Health, Inc.
Job Title: DI/QC & Admin Lead
Job Code: A011.9648
**Job Location: **Santa Clara, CA
Job Type: Full-Time
Rate of Pay: $150,000 - $170,000
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.
This job posting is anticipated to close on 6/2/2026.
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.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.
• For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
**Required Skills: **
Preferred Skills: