Specialist QA
11 hours ago
SUMMARY
Perform one or more of the following duties and responsibilities in support of 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.
REQUIREMENTS:
- Doctorate OR Masters + 2 years of directly related experience OR Bachelors + 4 years of directly related experience OR Associates + 8 years of directly related experience OR High school/GED + 10 years of directly related experience.
- NPI, Change Control, FATs, Validation, and PPQs
Job Type: Full-time
Pay: $ $40.00 per hour
Experience:
- Validation: 5 years (Preferred)
- PPQs: 5 years (Preferred)
- New Product Introduction (NPI): 5 years (Preferred)
- Change Control: 5 years (Preferred)
- FATs: 5 years (Preferred)
Work Location: In person
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