Quality Assurance Specialist - Drug Product

Provide Quality oversight of drug product manufacturing, packaging and inspection operations at a leading biotechnology company in Juncos, Puerto Rico. You will work with minimal supervision and make the quality calls that keep product moving.

What you'll do

• Review and approve master production records, process validation protocols and reports.
• Approve change controls, nonconformances, investigations and CAPA records.
• Represent Quality on incident triage and new product introduction teams.
• Review risk assessments, work orders and EMS/BMS alarms.
• Provide lot disposition and authorize lots for shipment.

Requirements

• Bachelor's degree + 4 years (or Master's + 2, Associate's + 8, or High School + 10) of directly related experience.
• GMP Quality Assurance experience approving change controls, deviations, CAPAs, protocols and procedures.
• Packaging and/or inspection operations experience preferred.
• Good Documentation Practices and electronic quality systems.
• Bilingual English/Spanish.

Benefits

• Contract: 5 months, with possible extension
• Shift: Administrative, Monday–Friday (40 hours/week)
• Start: Immediate