Quality Assurance Specialist - Drug Product

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 39,000 - 52,000; Full time

Job summary

BioPharma Consulting JAD Group in Juncos, Puerto Rico, seeks a Quality oversight professional to oversee drug product manufacturing, packaging and inspection operations with minimal supervision. You will make the quality calls that keep product moving.

Responsibilities include reviewing master production records, approving change controls and CAPAs, representing Quality on incident triage and new product introductions, and providing lot disposition for shipment.

Qualifications

• 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.

Responsibilities

• 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.

Skills

GMP QA experience

Bilingual English/Spanish

Good Documentation Practices

Electronic quality systems

Education

Bachelor's degree + 4 years experience

Job description

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