Quality Analyst III, Annual Product Review
Location:
Fort Washington , Pennsylvania
Posted:
January 23, 2017
Reference:
5589170109/2-en-us

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 data.
  • 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 necessary.
  • Actively work with stakeholders and reviewers to ensure the document meets SOP and standard requirements and is accurate and concise.
  • 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 approval.
  • 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.


Qualifications
  • 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 is required.
  • 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 preferred.
  • Six Sigma certification or process excellence training is preferred.
  • Technical writing experience/skills are highly preferred.
  • 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 needs.


Primary Location
United States-New Jersey-Skillman
Other Locations
North America-United States-Pennsylvania-Fort Washington
Organization
J & J Consumer Inc. (6101)
Job Function
Quality Systems

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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