Quality Specialist - Night Shift

Flexible & Integrated Technical Services, LLC • Juncos, PR

5d • Onsite

About The Position

We are seeking a Quality Specialist for the Downstream area within QA Services. This role requires a strong technical background in quality systems and validations, along with excellent interpersonal skills. The ideal candidate will be bilingual, possess project management abilities, and be comfortable working the 3rd shift (5:30 PM - 5:00 AM) and as per business needs. You will be part of a dynamic team that values teamwork, ethical conduct, and the scientific method, working in a lab environment with state-of-the-art equipment.

Requirements

• Bachelor's Degree
• Five (5) years of experience within the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Experience in Quality System and Validations.
• Experience with PASx/MES application, MAXIMO, SAP, LIMS, QMTS and Veeva.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level