Job Description

Job Title: QA Associate

Department: Quality Assurance

Reports To: QA Operations Manager

Position Overview

Reporting to the QA Operations Manager, the QA Associate primarily supports document management, deviation investigations, CAPA implementation, QA on-the-floor support, and quality data review.

Key Responsibilities

-          Coordinate and maintain the document control system.

-          Review, approve, and archive controlled documents (SOPs, batch records, etc.).

-          Investigate deviations, determine root causes, and propose CAPAs.

-          Monitor and track CAPA progress and effectiveness.

-          Assist with internal and external quality audits.

-          Ensure compliance with cGMP and other regulatory requirements.

-          Provide training on QA processes and on-the-floor support.

-          Identify and support process improvements for QA function.

Qualifications

-          Bachelor's degree in a relevant scientific field or equivalent experience.

-          Minimum of 2 years of quality assurance experience in biotech/pharma industry.

-          Experience in document management, investigations, and CAPA processes.

-          Familiarity with cGMP and other relevant quality standards.

-          Excellent communication and organizational skills.

Additional Information

-         Compensation commensurate with experience.