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
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
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
- Collect and analyze data to
detect duplicated effort, trends or non-compliance with regulations, and
- 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
- 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
- Metrics collection
- A minimum of a Bachelor’s degree (or equivalent degree) is
- A minimum of 4 years of experience in a highly regulated industry
- 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
- Proficient experience with Excel is required.
- The position will be located in Skillman, NJ, Tobyhanna, PA,
Fontana, CA or Mooresville, IN.
United States-New Jersey-SkillmanOther Locations
North America-United States-Pennsylvania-Tobyhanna, North America-United States-Indiana-Mooresville, North America-United States-California-FontanaOrganization
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.