Janssen Pharmaceuticals, Inc. is actively recruiting for a Stability Coordinator to be based in Raritan, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
This position pertains to Life cycle management of stability study samples within JPQ.
The job holder has the authority to request DEA Import permits, coordinate intra-site shipments, initiate stability studies according to approved protocols, distribute reference standard/stability pulls according to SOP, and communicate stability requirements to customers (e.g. manufacturing & packaging sites).
The scope of this role includes, but is not limited to:
• Ensure all drug product cGMP stability commitments are met by interacting with manufacturing sites, packaging sites, other stability coordinators and customers
• Ensure all annual commitments are verified & labeled upon receipt into the Stability Monitoring Program and all monthly pulls are performed on time to meet regulatory commitments
• Responsible for coordinating the acquisition, transportation, receipt, storage, chamber pulls and shipment for Stability samples and associated Reference standards from a global network of packaging facilities.
• This role will also interact with the manufacturing and packaging sites to ensure awareness of current stability policy and commitments, and to procure the necessary batches for the program; review stability commitments regularly to eliminate unnecessary duplication of product put-ups on the stability program; ensures accurate inventory and chain of custody records for all products are maintained; and will provide samples to the stability laboratory on a scheduled and as-needed basis making sure all samples are pulled within compliance.
• This role will also assist intradepartmental groups with sample and reference standard procurement for investigations, method transfers and training; maintain LIMS database; add Annual Commitments to database yearly and developmental commitments as needed, and will update protocols and studies as needed in LIMS database.
• This position is also responsible for Controlled Substance management, and to track and maintain controlled substance inventory from sample arrival to disposal.
• Assist with publishing metrics on-time. Assist Stability Owner with information inquiries on studies. Collaborate interdependently with internal and contract facilities to ensure understanding of required testing deadlines. Ensure adherence to SOPs.
• This role is also responsible for oversight of the qualification, performance, maintenance, and calibration of stability chambers which includes availability for response to any possible chamber excursions. Diligently responds 24/7 to chamber excursions and notify appropriate managers on system status; maintains stability chambers to ICH guidelines and is the first line notification for Environmental Monitoring System; document chamber maintenance, repairs and excursions in logbooks as required including product impact assessment; as well as regularly review chamber contents to optimize organization by removing expired products.
• Perform chamber monitoring inspections as required. Update and maintain the appropriate SOPs for the sample program. Provide oversight and update Maximo software for planning/ scheduling of PM and calibrations for chambers. Technical writing of investigations and CAPA related to stability program management, and will author and oversee Change Controls as needed. Qualifications
• This position requires a minimum of a Bachelors of Arts or Sciences in related field
• A minimum of 5 years of relevant working experience in pharmaceuticals is required.
• A minimum of 5 years in a pharmaceutical stability program environment is preferred.
• The ability to accurately and in a timely fashion, report stability related information is preferred.
• Knowledge of different IT systems: LIMS, SAP, Maximo, etc., is required.
• Sample & Chamber Management experience is required.
• Excellent technical writing skills are required.
• Knowledge of current stability guidelines, stability procedures is an asset.
• Knowledge of cGMP is required.
• Strong interpersonal skills, with the ability to maintain successful team relationships while also working independently is required.
• This position is located in Raritan, NJ and requires support of both Raritan and Titusville sites.
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United States-New Jersey-RaritanOrganization
JANSSEN SUPPLY GROUP, LLC (6046)Job Function
Quality ControlRequisition ID