• Share :

Description:

  • Perform one or more of the following duties and responsibilities in support of Company's Quality Assurance program under minimal supervision.
Functions:
  • Review and approve product MPs.
  • - Approve process validation protocols and reports for manufacturing processes. - Request Quality on incident triage team.
  • - Approve Environmental Characterization reports.
  • - Release of sanitary utility systems.
  • - Approve planned incidents.
  • - Represent QA on NPI team.
  • - Lead investigations.
  • - Lead site audits.
  • - Own site quality program procedures.
  • - Designee for QA manager on local CCRB.
  • - Review Risk Assessments.
  • - Support Automation activities.
  • - Support facilities and environmental programs.
  • - Review and approve Work Orders.
  • - Review and approve EMS/BMS alarms.
  • - Approve NC investigations and CAPA records.
  • - Approve change controls.
  • - Provide lot disposition and authorize lots for shipment.
Education:
  • Doctorate degree.
  • Master's degree and 3 years of directly related experience
  • Bachelor's degree and 5 years of directly related experience
  • Associate's degree and 10 years of directly related experience
  • High school diploma / GED and 12 years of directly related experience.
Preferred Qualifications:
  • Knowledge in Warehouse and Incoming QC operations, in quality oversights, in quality records such as deviations, CAPAS, change controls, and data integrity concepts.
Skills:
  • Project management skills.
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Initiate and lead cross functional teams.
  • Enhanced skills in leading, influencing and negotiating.
  • Strong knowledge in area of expertise.
  • Collaborate and coordinate with higher level outside resources.
  • Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
  • Demonstrate ability to interact with regulatory agencies.
  • Strong word processing, presentation, database and spreadsheet application skills.
  • Strong communication (both written and oral), facilitation and presentation skills.
  • Strong skill in working independently and to effectively interact with various levels.
  • Advanced data trending and evaluation.
  • Ability to evaluate compliance issues.
  • Demonstrate the Company's Values/Leadership Practices.
Work Methodology:
  • 100% On-site
  • 3 years
  • 3rd Shift (9:00pm to 5:30 am)
  • Professional Services Contract

Read the full job description and apply online on the recuiter's web-site

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