Quality Assurance Specialist, Drug Product NPI and Validation

Job overview

Quality Assurance Specialist, Drug Product NPI and Validation is an onsite, full-time role in Juncos, PR. Compensation is not specified. The specialist provides quality oversight for drug product operations at a biotechnology company, focusing on new product introductions, change control, and validation. The role reviews and approves quality records, leads investigations and audits, and supports lot disposition and shipment authorization. Its work helps maintain quality oversight and keep product and project activities moving through established processes.

What you'll do

• Represent Quality Assurance on new product introduction teams and support FATs
• review and approve process validation protocols and reports, including PPQs
• approve change controls, planned incidents, nonconformance investigations, and CAPA records
• review production records, risk assessments, work orders, and alarms
• lead investigations and site audits
• maintain site quality procedures
• provide lot disposition and authorize lots for shipment.

What we're looking for

Skills & competencies

quality assurance specialist

drug product

new product introduction

validation

gmp

change control

ppq

juncos pr

biopharma consulting jad group

onsite

monday–friday

four-month contract

Work arrangement

• Weekend coverage required

Why this role

The posting describes a four-month contract with possible extension, an administrative Monday–Friday schedule of 40 hours per week, and a November 2026 start. A bachelor’s degree plus four years of related experience is one listed qualification pathway.

About the employer

BioPharma Consulting JAD Group is hiring for this role. Industry: Biological Product (except Diagnostic) Manufacturing. Sector: 32.