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 &
- 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
- 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
- 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)
- 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.
United States-New Jersey-SkillmanOrganization
J & J Consumer Inc. (6101)Job Function