Exp CRS ELM Quality Control Analyst

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Equipment Lifecycle Management (ELM) Specialist in Malvern, PA!

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/.

The ELM Specialist is responsible for stability lab readiness for onboarding of new lab equipment and instrumentation, as well as performing the required tasks associated with this onboarding (i.e., Software Validation, Equipment Qualification, Validation, Data Integrity Risk Assessments, etc.).

The ELM Specialist will reside in Malvern PA location to provide support.
Key Responsibilities:


* Lead activities such as equipment purchase, qualification, computer systems validation (CSV), troubleshooting, metrology, calibration, and maintenance


* Participate in the execution of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification protocols of lab instrumentation and data management applications


* Maintain lab equipment in a validated state following established GxP regulations


* Support system upgrades, maintenance, and roll-outs of new systems, as needed and review/approve CSV documents including reviewing of Change Requests


* Collaborate with Global Quality Systems, IT, and site facilities to support ongoing instrument and applications troubleshooting, maintenance, retirement, and change management


* Create change controls for new or existing equipment and initiate Quality Event Management events for equipment not meeting protocol requirements, as applicable


* Ensure compliance to Janssen Quality global and local procedures, regulatory/HA requirements, and industry standards and maintain data integrity standards for all laboratory equipment and instrumentation


* Maintain high level of familiarity with GMPs, CFR Part 11, and current regulatory guidelines related to instrument calibration and CSV (e.g., GAMP 5, USP , 21 CFR Part 210/211 etc.)


* Develop and review laboratory technologies procedures and verify their compliance with internal and external requirements


* Interact with QC Analysts to cultivate open dialogue regarding equipment metrology, maintenance, calibration, and repairs


* Negotiate/set-up vendor contracts/Purchase Orders (PO), ensuring all GMP vendors are listed on Approved Service Provider and 3rd Party Service Provider list and all assessments are performed and reviewed

Qualifications:
Education:


* Minimum of Bachelor's degree or equivalent degree ...