Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Specialist QA
• Shift: Mon/Tue then Fri/Sat/Sun on alternate weeks from 5:00 AM to 5:30 PM or from 5:00 PM to 5:30 AM.

Summary
Quality Professional with Manufacturing Process Audit and Batch Record Review experience. In addition, some knowledge or to be familiar with DAI process, PASx/MES application, MAXIMO, SAP and LIMS.

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/LICENSES
- Doctorate degree, or Master's degree and 3 years, or Bachelor's degree and 5 years of directly related experience.