Johnson & Johnson Consumer Inc., a member of Johnson
& Johnson's Family of Companies, is recruiting for a Quality Analyst III,
Annual Product Review to be based in Skillman, NJ or Fort Washington, PA.
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 Quality Analyst III, Annual Product Review will:
- Ensure ongoing QA compliance functions are met
for Annual Product Reviews (APRs).
- Function as a liaison between internal J&J
departments and External Manufacturers/Packaging Sites (EMs) to gather required
- Utilize various J&J systems and databases to
retrieve information for incorporation into APRs.
- Compile, organize, and analyze information from
External Manufacturers (EMs) and internal J&J data to create a
comprehensive view of the manufacturing and/or packaging of an externally
manufactured or packaged product.
- Ensure, with the assistance and support of
Quality Account Managers/Leads/Specialists and reviewers, that APRs are
completed according to procedure and approved within required timelines.
- Actively manage the Annual APR schedule to
ensure due date adherence, identification of issues and delays, updates and
changes during the current year and for the following year.
- Notify EMs and J&J contributors of expected
document summaries and timelines and ensure adherence to those timelines.
- Compile product data for the review period,
including manufacturing and laboratory investigations, product quality
complaints, stability data, product quality related returns, change controls,
specification changes, validation activities, etc.
- Request and compile all internal J&J data,
reviewing and summarizing data presented in an Executive Summary.
- Review and analyze information provided by EMs
to ensure accurate and complete; obtain corrections/clarifications when
- Actively work with stakeholders and reviewers to
ensure the document meets SOP and standard requirements and is accurate and
- Provide a complete APR document for review and
approval in a timely manner; identify any negative trends indicating concern
for the product quality and initiate corrective actions upon management
- Participate in, lead, and/or coordinate meetings
related to APR process and participates in cross-functional teams as required.
- Ensure through APRs that the quality systems are
in accordance with the GMPs, procedures and regulations established by the FDA.
- Provide support during regulatory inspections
and internal audits as an SME for the system and process.
- Collect and provide metrics to management
regarding the APR process.
- Understand and perform statistical analysis of
internal or external manufacturer data included in the APR; identify and
evaluate shifts and trends.
- Conduct, execute and document thorough
investigations and CAPAs for high risk/high complexity issues.
- Review and approve compliance records and
documents as required by procedure.
- Facilitate the introduction of new processes and
procedures in support of process optimization and improvement initiatives.
- Author Standard Operating Procedures (SOPs) and
conduct user training in support of APR processes.
- A minimum of a Bachelor’s degree (or equivalent
degree) is required.
- A degree focused in a technical field
(Chemistry, Engineering, Sciences, Pharmacy or similar disciplines) is preferred.
- A minimum of 4 years of professional experience
in a regulated industry (Pharmaceutical, Medical Device, OTC Drug, Cosmetic,
and/or Food and Dietary Supplements Industry) is required.
- Detailed working knowledge of cGMP requirements
and current FDA enforcement issues is required.
- Strong knowledge of CFR 210, 211, 820 and CAPA
- A general understanding of OOS (Out of
Specification) and OOT (Out of Tolerance) results is required.
- Working knowledge of manufacturing control
systems is preferred.
- Experience with SAP, SharePoint and LIMS is
- Six Sigma certification or process excellence
training is preferred.
- Technical writing experience/skills are highly
- GMP manufacturing, laboratory experience, and/or
pharmaceutical regulatory experience preferred.
- Experience in writing and assembling Annual
Product Reviews is preferred.
- Proficiency in MS Word, Excel, and Power Point
applications is required.
- Experience in Statistics and experience with
related software programs is preferred.
- This position will be located in Skillman, NJ or
Fort Washington, PA and may require up to 10% travel depending on business
United States-New Jersey-SkillmanOther Locations
North America-United States-Pennsylvania-Fort WashingtonOrganization
J & J Consumer Inc. (6101)Job Function
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.