Account Supervisor - Pacific Communications in Madison, NJ
Sr. Sample Coordinator Stability
Company: Johnson & Johnson Location: Raritan, NJ Employment Type: Full Time Date Posted: 09/04/2021 Expire Date: 11/24/2021 Job Categories:
Biotechnology and Pharmaceutical, Information Technology, Installation, Maintenance, and Repair, Manufacturing and Production, Quality Control, Research & Development, Environmental
Sr. Sample Coordinator Stability
Janssen Supply Chain Group, LLC., a member of Johnson & Johnson's Family of Companies is recruiting for a Sr. Sample Coordinator Stability!
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Chain Group, LLC., is part of the Janssen Pharmaceutical Companies.
This position leads and executes day-to-day Quality Control sample management activities for the NJ Stability laboratory, ensuring GMP compliance and accuracy and timeliness of specified stability processes. Carries out duties in compliance with all local, state, federal and international regulations and guidelines (including FDA, EPA, OSHA, DEA, etc.) as well as all company and site policies and procedures.
This position leads and assures quality & compliance for all sample management activities and ensure all regulatory commitments are met, including compliance to stability pull windows. They will act as a stability operations SME for issues that arise in the area of Sample Management.
Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!
Responsible for the efficient and effective functioning of the Quality Control Stability Studies Sample Lifecycle Management Program
Ensure all stability commitments are met by interacting with manufacturing sites, Quality Owners/Integrators, and the stability lab personnel
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 proactively requesting DEA Form 222 from other sites when planning for shipment of controlled samples
Responsible for managing the accurate receipt and storage of incoming sample shipments to the site, as well as the accurate shipping of samples to various other labs/sites
Responsible for management of the site Reference Standard Program
Responsible for starting new studies (placing samples in chambers) on the day that they are approved for study start
Ensure all annual stability commitments are verified & labeled upon receipt into the Stability Monitoring Program and all monthly pulls are performed on time to meet regulatory commitments
Conducts Semi-annual inventory check of all controlled substances and reference standards
Review lab documentation, eLIMS data accuracy, trending, etc. as it relates to sample management
Ensure temperature control and humidity of stability chambers, including chamber mapping schedule maintenance
Diligently respond 24/7 to chamber excursions and notify stakeholders on system status
Maintain stability chambers to ICH guidelines and is act as the first line notification for the Environmental Monitoring System
Document chamber maintenance, repairs and excursions in logbooks as the need arises
Update protocols, studies and samples as needed in eLIMS database
Provide samples to the stability laboratory on a scheduled and as-needed basis making sure all samples are pulled within compliance
A minimum of a University / Bachelor's Degree (Science or Related)
A minimum of four (4) years of relevant experience
Ability to work with and lead others in a team environment
Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems
Detailed knowledge of compendial (USP, EP, JP, etc.) requirements and standards for QC testing
Strong interpersonal and written/oral communication skills
Ability to quickly process complex information and often make critical decisions with limited information
Ability to lead multiple priorities daily while being flexible and responsive to frequently shifting priorities
Proficient in applying process excellence tools and methodologies
Ability to independently manage a portfolio of ongoing projects
Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)
Controlled Substance handling experience
Prior experience in stability sample management
Preferred experience in a regulated quality environment, specifically within stability operations
This role may support both the Raritan and Titusville NJ locations, therefore routine travel between both sites is expected.
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.
Primary Location United States-New Jersey-Raritan-1000 US HIghway 202 Organization JANSSEN SUPPLY GROUP, LLC (6046) Job Function Quality Requisition ID 2105962777W