Johnson & Johnson Consumer Inc., a member of Johnson &
Johnson's Family of Companies, is recruiting for a SAP/MES Quality Assurance
Lead to be based in 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
The SAP/MES Quality Assurance Lead will:
- Provide quality and administrative support to the SAP and MES
- Provide QA support during SAP GxP Master Data creation.
- Support multiple functions within Quality and promptly generate
required reports for internal and external audits.
- Interact with internal and external entities to drive system
improvements and upgrades to SAP and MES systems.
- Provide daily Quality Assurance support to the manufacturing site
to ensure internal and regulatory cGMP and CFR requirements are met.
- Quality Assurance support areas include but are not limited to
Batch Record Review, Product Release, Raw material and packaging components
review and approval, Standard Operating Procedures review approval, Change
Control support as an SME and Shop Floor Quality supports.
communicate and provide guidance to respective areas on GMP issues observed
during review of documents. Support resolution efforts as needed.
- Interact with other departments including Manufacturing,
Packaging, Quality Laboratories, Quality Systems, Validation, Engineering,
Maintenance and other departments as it relates to site Quality Assurance
guidance to manufacturing operations, other Quality areas and others as needed
to insure receipt and approval of all production documents needed for review
quality related transactions in the following systems as required: SAP, Excel,
LIMS and EtQ.
issues discovered during batch record review to management for issues that are
deemed critical or impacting released product.
- A combination of the following education and experience is
required: A minimum of a Bachelor’s degree and 4 years of GMP experience or an
Associate’s degree and 8 years of GMP experience
- A degree focused in Science, Computer Science or Engineering is
- Strong knowledge of SAP and MES electronic systems required
- Expert knowledge/understanding of Batch Record Review, Product
Release, Raw material and packaging components review and approval is required
- Ability to interpret and apply GMP requirements is required
- Expert knowledge/understanding of drug manufacturing and packaging
processes from sampling and inspection through warehouse distribution is
- Expert knowledge/understanding in various computer systems: ERP,
LIMS, MES and Microsoft Office (including Outlook, Word, Project, Excel,
PowerPoint) is preferred
- Intermediate understanding of PLC programs is preferred
- This position will be located in Fort Washington, PA and may
require up to 5% travel
United States-Pennsylvania-Fort WashingtonOrganization
J & J Consumer Inc. (6101)Job Function