Quality Systems Specialist

The resource should have 2-3 years of prior experience in a regulated cGMP environment.

Prior experience in the pharmaceutical /biotech sector is preferred. The resource should have a combination of experience in the Quality Assurance area along with knowledge of Facilities/Utilities design, maintenance, and validation.

Additional proficiency in the use of Excel, PowerPoint, Maximo, and TrackWise software is needed.

Key job responsibilities are:

1. Development and generation of weekly/monthly QA group metrics. The metrics tracked will be validation document turnaround, Quality System records turnaround, and other group throughput data.

2. Performing first line review of unscheduled Maximo work orders and equipment job plans. The resource will be required to understand basic GMP requirements for calibration and maintenance of GMP utility and support systems such as HVAC, qualified gas systems, and purified/ distilled water systems.

3. Performing periodic reviews of operational/maintenance procedures and forms as the quality assurance representative. The resource should have a working knowledge of key concepts that are required for GMP compliant standard operational procedures.

4. Performing quality reviews of validation life cycle documents such as system impact assessments, equipment risk assessments, user and functional requirements specifications, validation protocols and reports.

5. Supporting Quality Systems activities such as Deviations, Change Controls, and CAPA records. The resource should be familiar with the use of TrackWise software and how to review and participate in quality systems investigations and corrective action projects.

All your information will be kept confidential according to EEO guidelines.