Preclinical Lab Ops Admin

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profile Job Location:

Santa Clara - USA

profile Monthly Salary: $ 56350 - 89930
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

R&D Operations

Job Sub Function:

Laboratory Operations

Job Category:

Business Enablement/Support

All Job Posting Locations:

Santa Clara California United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for Preclinical Lab Ops Admin to be in Santa Clara CA.

Purpose:

The Preclinical Laboratory Operations Administrator in Preclinical Affairs will work within the animal facilities of Johnson & Johnson MedTech locations in Santa Clara CA. These facilities support the execution of preclinical studies required to competitively position robotic and digital solutions for regulatory approval and clinical acceptance. This is a hands-on role within the Preclinical and Clinical Engineering teams and represents an outstanding opportunity to work cross functionally with various groups that utilize the Clinical Labs. Assistance and support in this space will be essential to the development of Ethicons highly innovative digital surgery platform.

You will be responsible for:

Lab Operations:

  • Supporting various laboratory research studies and research activities
  • Laboratory supplies tools instrument procurement inventory and test article distribution
  • Assisting with GLP lab event coordination
  • Assisting with biohazardous waste management
  • Promoting environmental health and safety compliance in our labs per company policies
  • Assisting in reviewing and revising SOPs on a quarterly basis or when necessary
  • Shipping receiving and storing Cadaveric tissue and laboratory supplies

Quality Support:

  • Assisting in GLP audit readiness internally and externally
  • Supporting corrective action implementation able to perform root cause analysis and address the cause of the deviation
  • Providing documentation record and data reviews in accordance with internal SOPs and GLP regulations
  • Handling and maintaining the GLP Archives
  • Supporting training compliance over the Preclinical team
  • Supporting to execute pre-GLP study checklist with rest of the cross-functional team
  • Assisting in raw data verification and final QC study review
  • Providing oversight and tracking deviations/ CAPA
  • Generate data trends and analysis on key performance indicator
  • Able to observe procedure execution and be able to identify deviation from protocol and Facility related SOPs
  • Automate process and be able design workflows that are direct translation to GLP requirements
  • Generate datasheet and forms according to GLP requirements
  • Order lab supplies and keep track of inventory

Qualifications / Requirements:

  • Bachelors degree is required; Masters is preferred
  • Experience in a biotech laboratory environment is desirable
  • Some technical understanding of how to operate and handle various laboratory equipment is desired
  • Experience working in medical device is advantageous
  • Familiarity with GLP requirements is required
  • Interest and ability to learn surgical procedures in the Preclinical Lab environment
  • Attention to detail and good verbal and written communication skills are required
  • Able to support cross functional activities multi-task and show proactiveness
  • Familiarity working with Microsoft 365 applications such as Word Excel and PowerPoint is required

PHYSICAL WORKING CONDITIONS / REQUIREMENTS

  • Ability to lift up to 40 lbs
  • Be able to perform such duties as mopping floors wiping down lab surfaces
  • Shipping receiving and storing Cadaveric tissue and laboratory supplies
  • Assembly of laboratory furniture and equipment

LOCATION & TRAVEL REQUIREMENTS

  • Primary location of the position can be at either Johnson & Johnson MedTech animal facilities (Santa Clara CA).
  • Domestic travel may be occasionally required for training purposes (<10%).

COMPANY DISCLAIMER

Company management reserves the right to add delete or otherwise alter assigned duties at any time. To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The minimum qualifications listed are representative of the knowledge skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Additional Information:

The anticipated base pay range for this position is $56350 to $89930.

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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are unique...
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