Quality Assurance Associate III – 2nd shift
Location:
Fort Washington , Pennsylvania
Posted:
March 21, 2017
Reference:
8988170203-en-us

Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Associate III, 2 shift position 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 (OTC) products. 

 The Quality Assurance Associate III:
  • Provides daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met.
  • Provides daily ‘Shop Floor” QA support to warehouse, bulk manufacturing and packaging lines.
  • Provides leadership support to QA Shop Floor activities including communication of quality events to management. 
  • Performs or supports activities related to In-Process Testing, AQL’s, and/or Investigational Protocol Execution. 
  • Performs or supports activities related to GMP area Audits, PM activities review and approvals, Line or Area Cleaning Verifications, etc.
  • Performs or supports activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases, Participates in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP’s).
  • Provide QA support to various project teams as needed.
  • Actively supports Site metrics, compliance improvement and training initiatives.
  • Facilitate resolution of issues to improve site metrics.
  • Escalate issues discovered during batch record review to management for issues that are deemed critical or impacting released product.
  • Position is for 2 shift, Monday thru Friday but may require to work 1 shift on occasion when business needs dictate.


Qualifications
  • A minimum of a Bachelor’s degree (or equivalent) is required  
  • A degree focused in Science, Computer Science or Engineering is preferred
  • A minimum of 4 years of related experience within a GMP environment is required
  • Strong knowledge of regulatory cGMP and CFR is required
  • Knowledge/understanding of drug manufacturing and packaging processes from sampling and inspection through warehouse distribution is preferred
  • Knowledge/understanding of Batch Record Review, Product Release, Raw material and packaging components review and approval is required
  • Knowledge/understanding of the product development life cycle is required
  • Knowledge/understanding in various computer systems: ERP, LIMS, MES and Microsoft Office (including Outlook, Word, Project, Excel, PowerPoint) is preferred 
  • Understanding of PLC programs is preferred
  • Ability to interpret and apply GMP requirements is required
  • Ability to work 2 shift hours with flexibility for 1st shift when needed is required.
  • This position will be located in Fort Washington, PA and will require up to 5% local travel as business needs require.

Primary Location
United States-Pennsylvania-Fort Washington
Organization
J & J Consumer Inc. (6101)
Job Function
Quality Assurance

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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