Quality Assurance Specialist - Drug Product

Biopharma-Consulting-Jad-Group; Juncos (PR); Vor Ort; USD 45.000 - 67.000; Vollzeit

Zusammenfassung

Biopharma-Consulting-Jad-Group seeks an experienced Quality oversight professional to supervise drug product manufacturing, packaging and inspection operations in Juncos, PR. You will review master production records, approve change controls, and participate in incident triage and product introductions.

The role requires GMP QA experience, documentation discipline, and bilingual English/Spanish. Administrative shift, 40 hours per week, with a 5-month contract and potential extension.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

GMP QA experience

Documentation

Bilingual English/Spanish

Ausbildung

Bachelor's degree + 4 years experience

Master's degree + 2 years

Associate's degree + 8 years

High School diploma + 10 years

Jobbeschreibung

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.

• 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.

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