Janssen Pharmaceuticals, Inc. is actively recruiting for a Sample Coordinator to be based in Titusville, 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, creation of stability studies according to approved protocols, oversight and distribution of reference standard, manage stability pulls according to SOP, evaluation of vendor executed protocols for chambers and evaluate impact of repairs on stability product, and communicate stability requirements to customers (e.g. manufacturing & packaging sites).
The scope of this role includes, but is not limited to:
• Support Stability Coordinator/ lead Coordinator to ensure drug product stability commitments are met. Some interaction with manufacturing or packaging sites (learning collaboration internally/ externally)
• Ensure all monthly pulls are performed on time to meet commitments.
• Responsible for coordinating the acquisition, transportation, receipt, storage and chamber pulls for Stability samples and associated Reference standards from a global network of manufacturing facilities.
• Ensures accurate inventory and chain of custody records for all products are maintained, including counting samples, staging and chamber
• Maintain LIMS database with creation and stability pull
• Add Annual Commitments to database yearly and on as need basis.
• Controlled Substance management & Track and maintain controlled substance inventory from sample arrival to disposal.
• Collaborate to maintain chain of custody of controlled substances.
• Follow process and perform removal of expired studies
• Work with Coordinator and Lab Specialist to oversee the 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 (EMS).
• Learn and perform reviews in EMS system and demonstrate knowledge
• Document chamber maintenance, repairs and excursions in logbooks as required included product impact assessment.
• Ensure all calibrations (chambers and probes) are performed and documented appropriately.
• Learning IQ, OQ and PQ as well as uniformity mapping
• Learn concepts and process for change control process for changes or new equipment
• With supervision, understand ownership of documents (periodic review of SOP/WI), CAPA, investigations and change controls.
• This candidate may be required to initiate, write, and document events associated to the duties of this position utilizing manual and electronic systems.
• Technical writing of investigations and CAPA related to stability program management
• Makes suggestions for improvements for stability program and learn and apply lean concepts
• Work under supervision to author SOPS and work instructions, with proficient technical writing and attention to detail
• Ability to set up processes with lean concepts
• Must have attention to detail and the ability to perform multiple tasks at once, while ensuring that all SOP’s and quality standards are met.
• Assist with compiling or publishing metrics on-time.Qualifications
• This position requires a minimum of a Bachelors of Arts or Sciences in related field
• A minimum of 3 years of relevant working experience in pharmaceuticals is required.
• A minimum of 3 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, Trackwise, AmegaView, Docspace, 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 Titusville, NJ and requires support of both Raritan and Titusville sites.
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United States-New Jersey-TitusvilleOrganization
JANSSEN SUPPLY GROUP, LLC (6046)Job Function
Quality ControlRequisition ID