CAPA Report Specialist
North Chicago, IL 60064
Hours: 8am to 5pm, Monday through Friday
- 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.