QA Specialist — NPI, Validation & Change Control

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

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.