CAPA Report Specialist

North Chicago, IL 60064

Post Date: 02/08/2018 Job ID: 25887 Category: Professional

Hours: 8am to 5pm, Monday through Friday

Job Description:
  • Developing Corrective and Preventative Actions (CAPAs), and writing deviation investigation reports supporting non-conforming events.
  • Review and approve deviation and CAPA records, ensuring timely closure and adequate investigations have been performed to drill down to root cause.
  • Participate in and assist weekly deviation review board meetings to assess criticality of deviations and identify corrective and preventative actions.
  • With fellow QA members, review and approve master batch records, procedures, validation documentation, specifications, change controls, reports and forms.
  • Follow through with suppliers to receive investigation results, actions planned, closure of actions that supplier is taking by requesting for objective evidence.
  • Collect relevant monthly and quarterly metrics.
  • Work with Databases and electronic systems.
  • Writing change requests.
  • Technical investigations Writer (deviations, change controls, CAPAs)
  • Keep metrics on status of deviations and CAPAs.
  • 80-90% of this position is writing exception/deviation reports.

  • Must have strong experience with writing investigation and CAPA reports.
  • The more experience with CAPA and investigations the better.
  • Degree in Sciences (e.G. Biology, Chemistry), Pharmacy, or Engineering Degree or equivalent.
  • Minimum of 3 years' experience as a CAPA Technical Writer in a biotech or pharma environment.

For more information, please contact A-Line Staffing at 877-782-3334.


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