QA Lead - NPI, Validation & Change Control (4-Month)

Biopharma-Consulting-Jad-Group

Juncos (PR)

On-site

USD 55,000 - 83,000

Full time

4 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

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.