QA Specialist Hello

- Knowledge or experience with electronic batch record if possible. Syringe/Vial Manual inspection experience if possible.

- 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.

Shift: 12 hrs. shift structure (5:00am to 5:30pm / 5:00pm to 5:30am).

Education: Doctorate degree or Master degree and 3 years of directly related experience or Bachelor degree and 5 years of directly related experience or Associates degree and 10 years of directly related

Job Type: Contract

Pay: $35.00 - $40.00 per hour

Schedule:

• 12 hour shift

Experience:

• QA / CAPA / NC Deviations: 5 years (Preferred)
• QA Auditor: 5 years (Preferred)

Work Location: One location