Quality Assurance Specialist - Drug Product NPI and Validation

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

BioPharma Consulting JAD Group seeks a Quality Assurance professional to provide QA oversight for drug product operations in Juncos, Puerto Rico. The role emphasizes new product introductions, change control and validation, with minimal supervision and decisive quality calls to keep projects moving.

You will represent QA on NPI teams, review validation protocols and PPQs, approve change controls and CAPA records, lead investigations and audits, and authorize lot disposition for shipment.

Qualifications

• GMP QA experience with NPI, change control, validation and PPQs.
• FAT experience is a plus.
• Ability to lead cross-functional teams and interface with regulators.
• Strong data trending and written/oral communication skills.
• Bilingual English/Spanish preferred.

Responsibilities

• Represent QA on NPI teams and support FATs.
• Review and approve validation protocols and PPQs.
• Approve change controls, incidents, investigations and CAPA; QA designee on the RCCB.
• Review/approve MPRs, risk assessments, work orders and EMS/BMS alarms.
• Lead investigations and site audits; own site quality procedures.
• Provide lot disposition and authorize lots for shipment.

Skills

GMP QA

NPI

Change control

Validation

PPQs

FAT

Manufacturing knowledge

Education

Bachelor's degree

Master's degree

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