Specialist QA

Flexible & Integrated Technical Services, LLC • Juncos, PR

2d • Onsite

About The Position

This role is within the QA Services area of the Technical Team. The ideal candidate will have a Bachelor's Degree with four years of experience in the pharmaceutical or regulated industry. Bilingual proficiency in English and Spanish is required, along with strong Project Management skills. The position operates on an administrative shift, adaptable to business needs. Key experience areas include Quality Assurance, encompassing the review and approval of change controls, deviations, CAPAs, protocols, reports, and procedures. Additionally, experience with packaging/inspection operations, strong knowledge of Good Documentation Practices (GDP), electronic quality systems, and effective collaboration with Manufacturing, Engineering, and Process Development are essential. The role thrives in an environment that values multitasking, scientific rigor, creativity, healthy competition, teamwork, ethical conduct, and the application of the scientific method.

Requirements

• Bachelor's Degree
• Four (4) years of experience within the pharmaceutical or regulated industry
• Bilingual (English & Spanish)
• Project Management skills
• Experience in Quality Assurance, including review and approval of change controls, deviations, CAPAs, protocols, reports, and procedures.
• Experience in Packaging/inspection operations
• Strong knowledge of GDP
• Strong knowledge of electronic quality systems
• Ability to collaborate effectively with Manufacturing, Engineering, and Process Development

Responsibilities

• 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