DI/QC & Admin Lead

Johnson & Johnson • Santa Clara, CA

1d • Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. This role works 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. The position involves conducting data review and inspection against procedures for an FDA compliant 21 CFR Part 58 laboratory, implementing Quality Control processes, overseeing quality checks of study documentation, supporting corrective action plans, monitoring deviations, ensuring equipment maintenance, overseeing archives, performing internal system inspections, and serving as a Subject Matter Expert on 21 CFR Part 58 for GLP compliance.

Requirements

• Master's degree in Biotechnology or related field
• 2 years of experience in the job offered or in a DI/QC & Admin Lead-related occupation

Responsibilities

• 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).

Benefits

• Consolidated retirement plan (pension)
• Savings plan (401(k))
• Long-term incentive program
• 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
• Medical benefits
• Dental benefits
• Vision benefits
• Time off
• Any others as provided for in the applicable Collective Bargaining Agreement

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees