Quality Assurance Specialist
hace 3 semanas
We are seeking a Technical Quality Professional to join our team at Flexible & Integrated Technical Services, LLC. This role will be responsible for ensuring the quality of our products and services.
About Us
We are a Service Provider company that integrates Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island and in the US. We pride ourselves on treating our employees with respect and care, providing them with flexible work arrangements and focusing on their well-being.
Responsibilities
The Technical Quality Professional will be responsible for reviewing and approving product Master Plans, process validation protocols, and reports. They will also request Quality on the incident triage team, approve Environmental Characterization reports, release sanitary utility systems, and approve planned incidents. Additionally, they will represent QA on the 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, and approve change controls. They will also provide lot disposition and authorize lots for shipment.
Requirements
To be successful in this role, you will need a Bachelor's Degree with five years of direct experience as a Quality Professional in the regulated industry. You must be bilingual (English & Spanish) and have project management skills. You should also be available to work non-standard shifts, including 5:00 AM - 5:00 PM and 5:00 PM - 5:00 AM, and be willing to support nights and weekends. Experience in Manufacturing Process Audit and Batch Record Review, DAI Process PASx/MES application, MAXIMO, SAP, and LIMS is also required.
What We Offer
We offer a competitive salary range of $85,000 - $115,000 per year, depending on experience. Our company culture values flexibility, family-orientedness, and employee well-being, while providing top-notch quality talent to our Pharmaceutical, Medical Device, and Manufacturing industry clients.
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