Quality Assurance Specialist - Drug Product NPI and Validation

Provide Quality oversight for drug product operations at a leading biotechnology company in Juncos, Puerto Rico, with a focus on new product introductions, change control and validation. You will work with minimal supervision and make the quality calls that keep projects and product moving.

What you'll do

• Represent QA on new product introduction (NPI) teams and support FATs.
• Review and approve process validation protocols and reports, including PPQs.
• Approve change controls, planned incidents, nonconformance investigations and CAPA records; act as QA designee on the change control review board.
• Review and approve master production records, risk assessments, work orders and EMS/BMS alarms.
• Lead investigations and site audits and own site quality program procedures.
• Provide lot disposition and authorize lots for shipment.

Requirements

• Bachelor's degree + 4 years (or Master's + 2, Associate's + 8, High School + 10, or a Doctorate) of directly related experience.
• GMP Quality Assurance experience with NPI, change control, validation and PPQs; FAT experience preferred.
• Strong knowledge of manufacturing, QA, validation and process development processes.
• Able to lead cross-functional teams and interact with regulatory agencies.
• Advanced data trending and strong written and oral communication.
• Bilingual English/Spanish preferred.

Benefits

• Contract: 4 months, with possible extension
• Shift: Administrative, Monday–Friday (40 hours/week)
• Start: November 2026