Johnson & Johnson Careers

Quality Control Technician - Stability Coordination (Raritan, NJ)

Raritan, New Jersey
Quality Control


Job Description

Requisition ID: 2502190816

Janssen Supply Group, LLC Part of the Janssen Pharmaceuticals Inc and Johnson & Johnson Family of Companies, is recruiting for a Quality Control Technician - Stability Coordination based in Raritan, NJ.

 

Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com

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.


Summary

The Quality Control Technician - Stability Coordination, is responsible for monitoring and maintaining stability samples and reference standards, pulling stability samples in a timely and compliant manner and performing other clerical tasks as it relates to stability sample management. This individual will provide support to stability coordinators in order to assure the timely pulling of stability samples. This position requires all actions to be completed in compliance with all applicable procedures, standards and GMP regulations as well as all local, state, federal and international regulations and guidelines (FDA, EPA, DEA, OSHA, etc.) This role supports both the Raritan and Titusville NJ locations, therefore routine travel between both sites may be required.

 
 
Responsibilities
  • Responsible for Stability Studies Sample Lifecycle Management for the NJ Stability Labs
  • Uphold our Credo values including creating a positive work environment
  • Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations
  • Perform sample management activities in compliance with all applicable procedures and cGMP regulations and in compliance with all local, state, federal and international regulations and guidelines (FDA, EPA, DEA, OSHA, etc.)
  • Stability Sample Management
  • Responsible for the daily pulling (physically and electronically) of samples in the stability chamber areas of the lab
  • Responsible for handling controlled substances in compliance with all applicable DEA regulations
  • Responsible for managing the proper receipt and storage of incoming sample shipments to the site, as well as the proper shipping of samples to various other labs/sites
  • Responsible for generating proper memos and organizing all required paperwork for shipment of samples
  • Responsible for management of the site Reference Standard Program, which entails the upkeep of in-house inventory, re-evaluation of retest dates, discarding of expired lots, and notifying lab personnel of any changes relevant to the standards they are requesting
  • Conducts Semi-annual inventory check of all controlled substances and reference standards
  • Conducts bi-monthly review of all USP reference standards Responsible for quarterly logbook reviews, chamber capacity reports, and switching out of temperature monitoring systems placed in all chamber areas
  • Check work orders daily in eLIMS for any end-of-window dates, to avoid any late pulls
  • Responsible for starting new studies (placing samples in chambers) on the day that they are approved for study start
  • Responsible for proper labeling of every study started
  • Regularly review chamber contents to optimize organization by removing expired products.
  • Make suggestions for improvements for stability program Diligently respond 24/7 to chamber excursions and notify appropriate managers on system status
  • Provide additional support to Stability Coordinators as needed
  • Other duties as assigned by management 



Qualifications
  • Required Minimum Education: High School Diploma
  • Minimum Required Years of Related Experience: 0 -2 years
  • Ability to work with others in a team environment
  • Ability to manage individual assignments with guidance from supervision/management
  • Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols
  • Required to pay close attention to detail, ensuring accuracy in documenting work in electronic systems or on paper
  • Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) 


Primary Location
United States-New Jersey-Raritan-
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality Control
Requisition ID
2502190816