HireDiversity

Raritan, NJ, US

Lab Specialist-2266121207

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 provides 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 Lab Specialist is responsible for varied day-to-day support for Stability Operations lab in Titusville and Raritan. This includes managing equipment qualification and calibration (coordinating vendors or performing calibrations, reviewing protocols and approving executed reports for accuracy); overseeing logistics of laboratory such as waste management, ordering supplies, and budget oversight (capital and expense spending); oversight of controlled substance program, including following JSC procedures, meeting DEA requirements; backup to stability coordinator including 24 hour on-call chamber support, setting up studies and interacting with SI/SO; and backup to training specialist.

He/she will perform review of equipment qualifications/calibration and maintenance protocols and approve executed vendor records and documentation. This individual will use Maximo software to maintain and schedule PM, calibration and service calls, and interact with analysts to foster open dialogue regarding equipment maintenance and repairs. This individual will be responsible for obtaining and storing Controlled Substance 222 form completions / approvals and will perform quarterly controlled substance inventory and approve completion. The Lab Specialist will be proficient in Trackwise, preparing change controls for incoming lab equipment, to decommission lab equipment and for ownership of lab events when issues arise, as applicable. The Lab Specialist will suggest continuous improvements for laboratory operations and efficiency, and implement ideas when warranted. This individual will negotiate/set-up vendor contracts/Purchase Orders for equipment, chemical supplies, lab coats, etc., and ensure that contractors supply cost-effective services in a compliant, timely fashion to keep the lab running efficiently. The Lab Specialist will prepare CARs for ordering of capital equipment and track capital and lab operations spending. He/she will interface with EHS for proper lab waste disposal to ensure safety in the lab. This individual will collaborate with Johnson Controls (facilities) for lab building and improvement requirements (e.g., DI water, Compressed gases, electrical) and support internal audits and Health Authority inspections, as SME for lab instrumentation support, and Controlled Substance program.

Qualifications


Bachelor of Arts or Science in related science or equivalent with a minimum of 5 years of relevant working experience in an analytical laboratory environment is required. Good technical knowledge of analytical instrumentation and IQ, OQ, and PQ requirements is required. Proficiency in Maximo and Trackwise is preferred. Change control experience is required. Strong understanding of instrument qualification, preventative maintenance and calibration is required. Understanding of stability program including controlled substance monitoring is preferred. This individual must have flexibility to travel between Raritan, NJ and Titusville, NJ as needed.

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 Control