Quality Specialist – Night Shift

About the role

We are seeking a bilingual (English & Spanish) Quality Specialist to join our QA Services team on the 3rd (night) shift. You will work in a laboratory environment supporting pharmaceutical and regulated‑industry manufacturing, applying scientific rigor and teamwork to maintain the highest quality standards.

Key responsibilities

• Review and approve product manufacturing procedures (MPs) and process validation protocols/reports.
• Approve environmental characterization reports, sanitary utility releases, and planned incidents.
• Represent QA on New Product Introduction (NPI) teams and lead investigations, site audits, and risk assessments.
• Own site quality program procedures and act as designee for the QA manager on the local CCRB.
• Support automation, facilities, and environmental programs.
• Review and approve work orders, EMS/BMS alarms, non‑conformance investigations, CAPA records, and change controls.
• Provide lot disposition decisions and authorize shipments.

Required profile

• Bachelor’s degree with at least five years of experience in the pharmaceutical or other regulated industry.
• Bilingual proficiency in English and Spanish.
• Strong project‑management abilities.
• Experience with quality systems, validations, and night‑shift work.

Required skills

• PASx/MES application
• MAXIMO
• SAP
• LIMS
• QMTS
• Veeva