Software Quality Assurance Engineer
hace 2 semanas
About Quality Consulting Group
We are a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry. We offer a world-class work environment in Puerto Rico & USA.
Job Description
This role involves working with our highly motivated team to review and approve product MPs, process validation protocols, and reports for manufacturing processes. You will also be responsible for approving Environmental Characterization reports, releasing sanitary utility systems, and more.
- 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
- Demonstrate ability to interact with regulatory agencies
- Approve NC investigations and CAPA records
- Approve change controls
- Provide lot disposition and authorize lots for shipment
Requirements
To be successful in this role, you should have a Bachelor's degree in Sciences and five years of directly related experience. Knowledge in Warehouse and Incoming QC operations, quality oversights, quality records such as deviations, CAPAS, change controls, and data integrity concepts is preferred.
We offer a competitive salary of $60,000 - $80,000 per year, depending on experience. This is a full-time position available for 3rd Shift (Monday to Friday 9:00pm - 5:30am).
Quality Consulting Group, LLC is an equal opportunity employer. We welcome all qualified applicants and consider factors such as race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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