Quality Assurance Specialist - Drug Product NPI and Validation

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 55,000 - 83,000; Full time

Job summary

Biopharma-Consulting-Jad-Group is seeking an experienced QA professional to provide quality oversight for drug product operations in Juncos, Puerto Rico. You will guide NPI introductions, change control, validation and PPQs, and act as QA designee on the change control review board.

Strong cross-functional collaboration and regulatory interaction are required. The role emphasizes minimal supervision, with responsibilities spanning lot disposition, site audits, and risk assessment reviews to

Qualifications

• GMP QA experience with NPI, change control, validation and PPQs.
• Strong knowledge of manufacturing, QA, validation and process development.
• Bilingual English/Spanish preferred.

Responsibilities

• Represent QA on NPI teams and support FATs.
• Review and approve process validation protocols and 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.

Skills

QA leadership

GMP QA

NPI

Cross-functional

Regulatory liaison

Education

Bachelor's degree in related field

Job description

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.

Qualifications

• 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.

Contract

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