Quality Assurance Associate

Position Overview

The Quality Assurance (QA) Associate supports the Quality unit in ensuring pharmaceutical manufacturing operations comply with cGMP , internal procedures, and regulatory requirements. This role partners closely with Manufacturing, Quality Control, and Engineering to maintain product quality and documentation integrity throughout the production lifecycle.

Job Responsibilities

• Review and approve GMP documentation, including batch records, logbooks, and manufacturing records
• Perform line clearances and in-process quality checks on the production floor
• Support deviation investigations, root cause analysis, and corrective and preventive actions (CAPAs)
• Assist with change controls, SOP revisions, and document control activities
• Ensure compliance with FDA regulations, company quality standards, and data integrity requirements
• Participate in internal audits, regulatory inspections, and quality system activities
• Support product release activities and quality disposition decisions as required
• Collaborate with cross-functional teams to resolve quality issues and drive continuous improvement

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field OR equivalent GMP manufacturing experience
• 0–3 years of experience in pharmaceutical, biotech, medical device, or regulated manufacturing environments
• Working knowledge of cGMP , FDA regulations (21 CFR), and quality systems
• Experience reviewing controlled documentation and manufacturing records preferred
• Strong written and verbal communication skills

Preferred Skills & Experience

• Exposure to deviation management, CAPAs, and change control systems
• Familiarity with electronic quality management systems (eQMS)
• Experience supporting audits or FDA inspections
• Ability to work in cleanroom and manufacturing environments