Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies,
is recruiting for a Quality Analyst III, Stability in Fort Washington, PA or
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.
Analyst III, Stability will:
the External Manufacturing (EM) stability program (within the Consumer Source
Quality Assurance expertise in the management of marketed product stability
(MPS) studies at EM and Contract Laboratory sites to ensure activities comply
with regulatory and J&J requirements.
as a Subject Matter Expert (SME) for MPS.
external stability testing sites by driving compliance and quality improvement
and guide Out of Specification/Out of Trend (OOS/OOT) and non-conformance
investigations (in partnership with Quality Engineers/Account Managers as
applicable) to ensure that J&J requirements are met.
externally generated stability data/certificates of analysis (COAs), protocols,
with J&J business partners, and participate on cross-functional teams
representing the EM stability group.
minimum of a Bachelor’s Degree in Chemistry, Biology, or related discipline is
minimum of 5 years of experience working in the pharmaceutical or similarly
regulated industry is required.
minimum of 2 years of experience in a Quality Assurance, Regulatory Affairs,
and/or Stability position is required.
with ICH guidelines, SUPAC, and other regulatory body of knowledge related to
stability programs is required.
with statistical software packages (e.g., Minitab, SAS, Statistica, JMP) is
of OOS and OOT investigations is required.
technical writing skills are required.
partnering with manufacturers, testing laboratories, R&D groups, and
technical operations is preferred.
working with solid and liquid dose products is preferred.
in MS Word, Excel, and Power Point applications is required.
position can be based in Fort Washington, PA or Skillman, NJ and may require up
to 10% domestic/international travel.
United States-New Jersey-SkillmanOther Locations
North America-United States-Pennsylvania-Fort WashingtonOrganization
J & J Consumer Inc. (6101)Job Function