Senior QA Associate — Batch Records & Deviation Lead

Mykelly; Juncos (PR); On-site; USD 34,000 - 48,000; Full time

Job summary

KellyScience, Engineering, Technology & Telecom (SETT) is seeking a Sr Associate QA for the east region in Puerto Rico. The role focuses on sampling plans, batch record reviews, and QA oversight to ensure compliance with quality standards and GDP guidelines.

The ideal candidate will have a science degree (or masters) with QA experience, strong documentation skills, and fluency in Spanish and English. Will work non-standard shifts, including weekends and holidays, across the facility.

Qualifications

• Bachelor's degree in Science or Master’s degree with quality experience.
• Quality experience including sampling plans and batch record review.
• Experience with deviations, GDP, and data integrity (ALCOA+).
• Fluent in Spanish and English; able to work all shifts, including weekends.
• Familiarity with SAP system and electronic batch records.

Responsibilities

• Perform sampling plans for drug products and batch record reviews.
• Audit inspection and packaging processes for compliance with procedures.
• Oversee QA operations, including deviation investigations and change controls.
• Contribute to SOP revisions to maintain quality standards.

Skills

Spanish

English

Education

Bachelor's degree in Science

Master's degree

Tools

SAP

Job description

KellyScience, Engineering, Technology & Telecom (SETT) is seeking a Sr Associate QA for the east region in Puerto Rico. The role focuses on sampling plans, batch record reviews, and QA oversight to ensure compliance with quality standards and GDP guidelines.

The ideal candidate will have a science degree (or masters) with QA experience, strong documentation skills, and fluency in Spanish and English. Will work non-standard shifts, including weekends and holidays, across the facility.