Quality Assurance Associate

Job Responsibilities

• Review batch records, logbooks, and supporting documentation for accuracy and completeness

• Ensure documentation complies with cGMP requirements and internal SOPs

• Initiate and support deviations, investigations, and CAPAs

• Assist with change controls and impact assessments

• Perform line clearances and in-process quality checks

• Support internal audits and regulatory inspections

• Maintain controlled documentation and support document revisions

• Track and trend quality metrics as assigned

• Collaborate with Manufacturing and QC to resolve quality issues in real time

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, or related field (or equivalent experience)

• 0–3 years of experience in pharmaceutical, biotech, or medical device manufacturing

• Knowledge of cGMP regulations and FDA guidelines

• Strong attention to detail and documentation skills

• Ability to work cross-functionally in a fast-paced environment