Specialist QA

Juncos - Puerto Rico

Monthly Salary: Not Disclosed

Experience Required: 4years

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

We are seeking a highly skilled and detail-oriented Specialist QA to support supply chain operations within a pharmaceutical environment. This role focuses on ensuring compliance and quality oversight across incoming material inspection warehouse floor audits and deviation management. The ideal candidate will bring technical expertise digital fluency and a strong understanding of regulated environments.

Primary Focus Areas

Perform sampling and inspection of incoming materials and components.

Conduct quality audits of warehouse floor operations to ensure compliance with SOPs and GMP standards.

Initiate investigate and approve quality deviations (nonconformances) in coordination with cross-functional teams.

Utilize Smartsheet Power BI SAP and Generative AI tools to manage quality data reporting and workflows.

Additional Responsibilities

Review and approve Master Production Records (MPs) and process validation protocols/reports.

Represent QA on New Product Introduction (NPI) teams and incident triage groups.

Approve Environmental Characterization reports and release sanitary utility systems.

Lead investigations and site audits; own site-level quality program procedures.

Act as designer for QA Manager on local Change Control Review Board (CCRB).

Review risk assessments work orders EMS/BMS alarms and planned incidents.

Approve NC investigations CAPA records and change controls.

Provide lot disposition and authorize product lots for shipment.

Support automation facilities and environmental compliance programs.

Requirements

Education in a relevant scientific or engineering discipline:

-Doctorate or

-Masters 2 years of directly related experience or

-Bachelors 4 years of directly related experience

We are seeking a highly skilled and detail-oriented Specialist QA to support supply chain operations within a pharmaceutical environment. This role focuses on ensuring compliance and quality oversight across incoming material inspection warehouse floor audits and deviation management. The ideal cand...