HireDiversity

Raritan, NJ, US

Stability Coordinator-6451130103

Description

Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provide access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.

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

The Stability Coordinator will be responsible for life cycle management of stability study samples within JSC. This individual will have 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 and packaging sites). In addition, this individual will be responsible for SME of LIMS system, investigation ownership and support of metrics for Lab Manager; acquisition and oversight of stability samples for Stability Integrator; and provide support to stability analysts. The scope of responsibilities for this position include:

Sample Management Ensure all drug product GMP stability commitments are met by interacting with manufacturing sites and the stability laboratory. 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 and chamber pulls for Stability samples and associated Reference standards from a global network of manufacturing and packaging facilities. 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. Update LIMS database as needed and ensure all data for batches are correct. Provide samples to the stability laboratory on a scheduled and as-needed basis making sure all samples are pulled within compliance. Assist intradepartmental groups with sample and reference standard procurement for investigations, method transfers and trainings. Maintain LIMS database. Add Annual Commitments to database yearly and on an as needed basis. Update protocols, studies and samples as needed in LIMS database. Controlled Substance management. Track and maintain controlled substance inventory from sample arrival to disposal. Collaborate with supervisors to maintain chain of custody of controlled substances. Assist with publishing inventory metrics on-time.

Chamber Management Oversee the performance, maintenance, and calibration of stability chambers which includes availability for response to any possible chamber excursions. Must be available to diligently respond 24 hours/7 days a week 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 included product impact assessment. Regularly review chamber contents to optimize organization by removing expired products. Ensure all calibrations are performed and documented appropriately. Perform chamber monitoring inspections daily or as needed basis. Data management. Assist SI/SO with information inquiries and report assembly by providing requested information and data tables. 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. Collaborate interdependently with internal laboratories, contract facilities and other external laboratories to meet required testing deadlines. Update and maintain the appropriate SOPs for the sample program. Ensure adherence to SOPs. Writes Deviation /Investigation records and completes SAP tasks as needed. Provide chamber condition and calibration information as requested. This candidate may be required to initiate, write, and document events associated to the duties of this position utilizing manual and electronic systems.

CAPA and Investigations Technical writing of investigations and CAPA related to stability program management.

General Makes suggestions for improvements for stability program. Author SOPS and work instructions, with proficient technical writing and attention to detail. Ability to set up processes with lean concepts. Ability to work independently and make compliant decisions for stability program.

Qualifications


Bachelor of Arts or Sciences in related field preferred. Minimum 5 years experience in supply chain required (pharmaceutical experience preferred). Demonstrated technical writing experience is required. Knowledge of compliance to applicable procedures preferred. Expertise in stability behavior of portfolio products preferred. Knowledge of different IT systems (LIMS, SAP, trackwise, etc) preferred. Sample and chamber management experience preferred. Knowledge of GMP's preferred. Strong interpersonal skills, ability to be customer focused, with a high sense of responsibility regarding professional activities is required. Must be able to maintain successful team relationships, promote knowledge sharing within the area, and possess good oral presentation skills. Commitment to timeframes, ability to be proactive, creative, open to change and improvement, and possession of an accurate and quality mindset is required. This position will be based in Raritan, NJ and will require travel to Titusville, NJ based on business needs.

Primary Location:North America-United States-New Jersey-Raritan
Other Locations:North America-United States-New Jersey-Titusville
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: Quality Assurance