TrentonRecruiter Since 2001
the smart solution for Trenton jobs

Change Control Analyst

Company: Janssen
Location: Raritan
Posted on: January 16, 2022

Job Description:

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Change Control Analyst, CAR-T. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to build a world without disease. Redefining lives by finding new and better ways to prevent, intercept, treat and cure disease encourages us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies. Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is crafted to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment. The Change Control Analyst, CAR-T is responsible for change control support for the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. As the Change Control Analyst, you will: Support process changes arising from updates to materials, excipients or finished goods requirementsSupport efforts to establish and streamline the site change control processAct as change control champion for operations by being responsible for the change control from Initiation through completionParticipate in global forums/team meetings for Change controlRun reports and conduct data analysis to support establishment and monitoring of change control for operations.Lead cross functional team meetings to prioritize updates to MBRs/ EBR/MES updates.Lead implementation of corrections / CPAs by working with SMEs, Correction/ CPA owners, and tech writers to maintain timelines.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Other duties will be assigned, as vital.QualificationsA minimum of a bachelor's degree is required.A minimum of six (2) years of related experience in a regulated and/or research environment is required.Experience in the Pharmaceuticals or related industry is required.Strong solid understanding of current Good Manufacturing Practices (cGMP's), initiating and completing change controls is required.Strong project management skills desired.Shown technical leadership within pharmaceutical or similar environment is helpfulExperience with the start-up of new biopharmaceutical manufacturing facilities is preferred.Experience with Trackwise or equivalent systems is preferredProficiency in English (verbal and written), strong communication skills and the ability to influence at all levels are required.Proficiency in Microsoft Office tools (Word, Excel, PowerPoint and Outlook) is required.Ability to accommodate changes in the schedule including working in other shifts as per operational needs is required.This position will be based in Raritan, NJ and requires up to twenty percent (20%) of domestic and international travel.At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.Primary LocationUnited States-New Jersey-Raritan-1000 US HIghway 202OrganizationJanssen Pharmaceuticals, Inc. (6062)Job FunctionOperationsRequisition ID2105992555W

Keywords: Janssen, Trenton , Change Control Analyst, Professions , Raritan, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

Trenton RSS job feeds