Quality Assurance Specialist - Drug Product NPI and Validation

BioPharma Consulting JAD Group

10d

About The Position

Provide Quality oversight for drug product operations at a biotechnology company in Juncos, Puerto Rico, focusing on new product introductions, change control, and validation. The role works with minimal supervision and makes quality decisions that keep projects and products moving. This is a four-month contract with a possible extension, on an administrative Monday–Friday schedule of 40 hours per week, starting in November 2026.

Requirements

• Bachelor's degree plus 4 years of directly related experience, or Master's degree plus 2 years, Associate's degree plus 8 years, High School diploma plus 10 years, or a Doctorate.
• GMP Quality Assurance experience with NPI, change control, validation, and PPQs.
• Strong knowledge of manufacturing, QA, validation, and process development processes.
• Ability to lead cross-functional teams and interact with regulatory agencies.
• Advanced data trending skills.
• Strong written and oral communication skills.

Nice To Haves

• FAT experience.
• Bilingual English/Spanish.

Responsibilities

• 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.

What This Job Offers

• Career Level: Mid Level