Quality Systems Document Management Associate (3 openings)

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

Job Function:
Quality

Job Sub Function:
Quality Documentation

Job Category:
Professional

All Job Posting Locations:
Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for Quality Systems Document Management Associates! There are three current openings for this role and they will be located in Raritan, NJ.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

The Quality Systems Document Management Associate will provide support for document management activities at Raritan Advanced Therapies.

Key Responsibilities:


* Issue and reconcile documents at Raritan Advanced Therapies


* Conduct document review/approval in tru VAULT ensuring adherence to local and global procedures


* Support records management in accordance with WWRIM (Worldwide Record Information Management) policies


* Support audit and inspections


* Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.


* Other duties can be assigned, as necessary.

Qualifications:

Education:

Minimum of a Bachelor’s or equivalent University degree is required.

Focus on Science or equivalent technical subject area is preferred

Experience and Skills:

Required:


* Minimum 2 years of relevant work experience


* Knowledge of cGMP regulations and FDA/EU guidance


* Strong communication (verbal, written, and presentation) and interpersonal skills, self-awareness, and adaptability.


* Highly organized and capable of working with a cross-functional team

Preferred:


* Experience in Quality Assurance/ Quality Systems related to document management


* Experience in a high-paced manufacturing environment


* Experience with processing documents via document management systems (such as Tru VAULT or equivalent EDMS)


* Ability to work in an ambiguous environment.

Other:

·       Weekend and off shift support may be required.

·       Requires up to 10% domestic travel.

Johnson & Johnson is an Equal Opportunity Employe...