Sr. Analyst, Quality System Execution (CLS)
Location:
Mooresville , Indiana
Posted:
February 07, 2017
Reference:
3388161208/3-en-us

Johnson & Johnson Customer & Logistics Services is recruiting for a Sr. Analyst, Quality System Execution (CLS), located in Skillman, NJ, Tobyhanna, PA, Fontana, CA or Mooresville, IN.

 

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. 

 

Johnson & Johnson Customer & Logistics Services (CLS) is a global Supply Chain organization that supports operating units across all of the Johnson & Johnson Family of Companies.

 

CLS strives to deliver an exceptional customer experience through leading critical customer facing-functions such as distribution and transportation. In addition, CLS oversees critical business enablers, including how we gather and manage supply chain master data, safe and secure supply chain practices, product identification standards, and market/channel access capabilities. CLS supports all three sectors of Johnson & Johnson: Medical Device & Diagnostics, Pharmaceutical, and Consumer Products. This team is represented in multiple countries, and continues to grow globally in both visibility and responsibility. The CLS team reports to Johnson & Johnson Supply Chain and partners closely with groups throughout the supply chain organization.

 
 
The Sr. Analyst, Quality System Execution (CLS) will:
 
  • Support the execution of Quality Management Systems and compliance with applicable procedures, laws and regulations at the CLS Distribution Centers.
  • Liaise with multiple Quality organizations (Make QA/Business Quality/Franchise QA) to drive timely resolution of Quality related issues (products and processes).
  • Support optimization of quality systems and processes alignment with the worldwide business, the quality vision. Support continuous improvement of quality, cost and time factors, consistent with both Sector and CLS business objectives.
  • Escalate significant business issues, support action, and support improvement opportunities and problem solutions in collaboration with other Distributions Centers.
  • Support quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties:
  • Evaluate Information to Determine Compliance with Standards — Using relevant information and individual judgment to determine whether events or processes comply with regulations or standards.
  • Identify opportunities to continuously improve quality systems.
  • Prepare detailed reports on audit findings and data analysis.
  • Provide employee training and or coaching on compliance related topics, policies, or procedures.
  • Obtain, organize, or develop training procedure manuals, guides, or course materials, such as handouts or visual materials on compliance related topics.
  • Create or revise controlled departmental documents.
  • Collect and analyze data to detect duplicated effort, trends or non-compliance with regulations, and management policies.
  • Examine ETQ records for efficiency, effectiveness, and use of procedures to record execution and compliance with regulations.
  • Identify information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.
  • Support activities at all Consumer DC sites.
    • Internal audit program
    • Process and systems related with cGMPs
    • Departmental Meetings (QSMR, Weekly Compliance Meeting, CAPA Review Board)
    • Quality System Metrics (Investigations, CAPAs, Effectiveness Checks and Change Controls)
    • Document Control process (ex: on time review)
    • ADPR and Annual Report Distribution Contribution
    • Metrics collection


Qualifications
  • A minimum of a Bachelor’s degree (or equivalent degree) is required.
  • A minimum of 4 years of experience in a highly regulated industry is required.
  • Quality Assurance/Quality Control experience in the Medical Device, Pharmaceutical, Consumer products or related industry and experience with regulatory inspections is required. Quality Assurance/Distribution Center experience is preferred.
  • Strong knowledge of FDA 21 CFR Part 210, 211 and 820 and/or ISO 13485, 9001:2008, 9001:2015 and/or ERP systems are required.
  • Strong communication, teamwork, problem solving, decision-making, data analysis, inductive reasoning, critical thinking and root cause analysis skills are required.
  • Six Sigma, Lean, 5S or ASQ Certification and trainings are preferred.
  • Proficient experience with Excel is required.
  • The position will be located in Skillman, NJ, Tobyhanna, PA, Fontana, CA or Mooresville, IN.


Primary Location
United States-New Jersey-Skillman
Other Locations
North America-United States-Pennsylvania-Tobyhanna, North America-United States-Indiana-Mooresville, North America-United States-California-Fontana
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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