Specialist, R&D Quality & Compliance
Location:
, New Jersey
Posted:
January 20, 2017
Reference:
4774161221-en-us

Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Specialist, R&D Quality & Compliance to be located in Skillman, NJ.

 

Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units:  Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.

 

The Specialist, R&D Quality & Compliance will:

 
  • Be responsible for documentation quality review/approval or audits, documentation maintenance and archival, quality inspections of product, and participating on internal assessments.
  • Assist in compiling documentation to release R&D studies and will provide guidance on applicable Regulations (FDA, ICH, EU, and others) pertaining to business partners.
  • Be responsible for the administration of integrated and comprehensive quality systems/controls in order to ensure that R&D functions are operating in full compliance with Current Good Manufacturing Practices (CGMP), and within Johnson & Johnson policies and Standard Operating Procedures.
  • Provide GMP documentation review and approval of batch records (Manufacturing, Packaging, and Labeling) and related documents, including Lab, Pilot, and Trial scale batches. Responsible for the quality inspection of supplies for R&D studies.
  • Participate on R&D project teams as the Quality representative.
  • Work with these groups relative to GMP issues, project plans, due dates, and problem identification and resolution along with assisting in compiling documentation to release R&D studies.
  • Provide Quality guidance on GMP regulatory requirements (including 21CFR Parts 50, 54, 56, 58, 210, 211, 312, 314, 812, 820, Part 11, and Annex 13), including training of R&D personnel.
  • Handle GMP documentation maintenance, storage, and archival process, including the daily activities supporting this process.
  • Participate in the development and implementation of GMP and Quality & Compliance processes and procedures.
  • Participate on and perform internal assessments of R&D GMP processes and areas.
  • Participate in inspection readiness activities.

Qualifications
  • A minimum of a Bachelor’s degree (or equivalent degree) in Chemistry, Biology, Engineering, or related science or technical discipline is required.
  • A minimum of 3 years of experience in a regulated (Pharmaceutical, consumer goods, and/or medical device) laboratory environment is required.
  • Working knowledge of applicable regulatory requirements (cGMPs and/or cGLPs) governing various product classification types (pharmaceutical, consumer, cosmetic, OTC/OTC Monograph and/or medical devices) is required.
  • Laboratory documentation review and revision experience is preferred.
  • Experience of the overall product development process is preferred.
  • Knowledge of quality systems (ETS, GSS, etc.) and investigation tools is preferred.
  • The position will be located in Skillman, NJ and may require up to 10% travel.


Primary Location
United States-New Jersey-Skillman
Organization
J & J Consumer Inc. (6101)
Job Function
R&D

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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