Quality Assurance Specialist - Drug Product

BioPharma Consulting JAD Group

2d

About The Position

Provide Quality oversight of drug product manufacturing, packaging, and inspection operations at a biotechnology company in Juncos, Puerto Rico. Work with minimal supervision and make quality decisions that keep product moving. This is a five-month contract with a possible extension. The schedule is administrative, Monday through Friday, 40 hours per week, with an immediate start.

Requirements

• Bachelor's degree and 4 years of directly related experience, or a Master's degree and 2 years, an Associate's degree and 8 years, or a high school diploma and 10 years.
• GMP Quality Assurance experience approving change controls, deviations, CAPAs, protocols, and procedures.
• Knowledge of Good Documentation Practices and electronic quality systems.
• Bilingual in English and Spanish.

Nice To Haves

• Experience in packaging and/or inspection operations.

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.

What This Job Offers

• Education Level: High school or GED