QA Specialist

Flexible & Integrated Technical Services, LLC • Juncos, PR

2d • Onsite

About The Position

This role is for a QA Specialist within the Quality Systems area for Manufacturing Services. The ideal candidate will have a Bachelor's Degree with five years of experience as a Scientist in the pharmaceutical or regulated industry. Bilingual (English & Spanish) skills and Project Management experience are required. The position involves a 12-hour shift from 5 pm to 5:30 am, with flexibility for business needs. Experience in performing batch record review, approval, and reconciliation, as well as oversight of manufacturing operations and management of events and decision-making, is essential. The company culture emphasizes teamwork, ethics, and the scientific method, offering a dynamic environment for those with multitasking, scientific, and creative skills.

Requirements

• Bachelor's Degree
• Five (5) years of experience as a Scientist within the pharmaceutical or regulated industry
• Bilingual (English & Spanish)
• Project Management skills
• Experience in performing batch record (EBR) review, approval, and reconciliation
• Experience in oversight of manufacturing operations
• Experience in managing events and decision making

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