QA Compliance Manager

Princeton, NJ
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Type: Direct-Hire

Category: Scientific & Clinical

Job ID: 152194

Date Posted: 05/22/2020


Title:  QA Compliance Manager

Location: Princeton, NJ

Schedule: 1st shift

Type: Direct Hire

Start date: ASAP

Responsibilities:

  • This position is compliance focused
  • Will have 1 direct report to start
  • Will have direct management/oversight of the Electronic Management System and Archive site
  • Investigation Metrics all all rapid decisions, have to be able to make decisions "real time"
  • Manage Princeton Administration role for Electronic Document Management System (EDMS)
  • Manage Princeton Document Archive
  • Manage Quality Assurance portion of training documentation
  • Support/Lead site initiatives for Inspection Readiness
  • Support Quality Management Systems (QMS) with QA review and decisions on; CAPAs, Change Controls, Customer Complaints, operational deviations, and Self-Inspection as needed

Requirements:

  • BS Degree with a minimum of 7 years of relevant industry experience in a GMP regulated environment
  • 5-7 years experience in a QA role within a Manufacturing setting, experience in a GMP Manufacturing setting
  • Clinical experience preferred but not required
  • Ability to make GMP decisions
  • Experience with investigations and root cause analysis
  • Experience with Change Controls, CAPA's and Deviations
  • Experience managing a QMS
  • Experience at managerial level either as an individual contributor or managing team members

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services.  For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.


 

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