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Quality

Data Integrity Specialist, Preclinical Operations

  • 标题 Data Integrity Specialist, Preclinical Operations
  • 功能 Quality
  • 子功能 Quality Assurance
  • 类别 Specialist Technician, Quality Assurance (S3)
  • 工作地 Santa Clara, California, United States
  • 发布时间
  • 申请ID 2406186135W
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描述

Johnson & Johnson Medtech is recruiting for a Data Integrity Specialist, Preclinical Operations. This position is located in Santa Clara, California.

At Johnson & Johnson Medtech, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH™), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative, rapidly growing teams in the San Francisco Bay Area (Redwood City and Santa Clara) and Cincinnati. You’ll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals’ skills and improves patient outcomes.

Overview

The Data Integrity Specialist of Preclinical Operations in Preclinical Affairs will work within the animal facilities of Johnson & Johnson MedTech locations in Santa Clara, CA and Redwood City, CA.  These facilities support the execution of preclinical studies required to competitively position robotic and digital solutions for regulatory approval and clinical acceptance. The position primary responsibilities involve review of data and auditing procedures that apply to an FDA compliant 21 CFR Part 58 laboratory to ensure they are capable of supporting Johnson & Johnson (J&J) Medical Device. May also be responsible for working on other projects requested by the Test Facility Manager. This will support the GLP program and operations across both locations and will report to the Test Facility Manager.  

POSITION DUTIES & RESPONSIBILITIES:

Under supervision of the Test Facility Manager and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will:

  • Perform internal audits against established policies and procedures for monitoring of animal husbandry, surgical lab execution, equipment use, and user training. Training file reviews will be completed to ensure staff training curriculum is established and up to date.
  • Perform Quality checks of Study documentation to include Data integrity review of study files.
  • Will track deviations and identify areas/processes that need correction or improvement including Identification of systemic issues and Identification of repetitive deviation.
  • Perform internal system audits against established policies and procedures including Electronic system usage, Animal Care and Use, Facilities: Maintenance and Qualification, Equipment: Maintenance and Qualifications, Archiving: Electronic, Physical, Wet Tissues, Test Article Retains, and Test Articles Dispensary.
  • Support these activities for all preclinical studies within the animal facilities at the Johnson & Johnson MedTech locations in Santa Clara, CA and Redwood City, CA.
  • Subject Matter Expert on 21 CFR part 58 for the Preclinical Research staff in the conduct of Good Laboratory Practices for Nonclinical Laboratory Studies.
  • Direct process improvements (develop/implement continuous quality improvement). 
  • Responsible for resourcing of lab activities and facility utilization.
  • Management of Purchase Orders and ordering of inventory and specimens.
  • Performs other duties assigned as needed.

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS 

  • Reports to the Senior Manager, Preclinical Operations (Test Facility Manager)
  • Internal interface activities include partnering with: 
    • Preclinical Study Directors 
    • Pathologists 
    • BRQC, Quality, QAU, Regulatory 
    • Other contracted staff 

资格

Education & Required Skills/Experience: 

  • A Bachelor’s Degree and a minimum of (2) years of experience in a preclinical operational role in a pharmaceutical, medical device, or contract lab setting (or related industry) is required
  • Demonstrated knowledge of preclinical practices and procedures
  • Advanced knowledge of 21 CFR part 58 and its application in a GLP Program
  • Ability to work cooperatively with coworkers

Preferred Skills & Experience:

  • Experience in the Medical Device industry or medical field
  • Knowledge of animal welfare and care regulations
  •  Demonstrated experience in GLP compliance

Other:

  • Must be able to stand for long periods of time.
  • Must be able to lift at least 30 pounds above his/her head. 
  • Primary location of the position can be at either Johnson & Johnson MedTech animal facilities (Santa Clara, CA and Redwood City, CA)
  • Regular travel back and forth between the two locations is required on a recurring basis.
  • Domestic travel may be occasionally required for training purposes (<10%).

The anticipated base pay range for this position is [$123,500] to [$166,000].

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. 

  

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. 

  

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  

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

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