Quality Assurance Associate

Quality Assurance Associate

Rockville MD Full-Time

Nexagen Search is representing a biotechnology company that is hiring for an Quality Assurance Assocuate to join their team in Rockville MD. This role will support the Quality Director by executing daytoday quality operations ensuring documentation integrity assisting with vendor / CMO oversight and helping maintain compliance with regulatory standards.

Key Responsibilities :

• Review control and maintain GMP documentation ensuring accuracy compliance and readiness for audits and inspections.
• Keep quality records organized and audit-ready including timely filing secure storage and preparation of controlled documents.
• Support vendor and CMO oversight by assisting with qualifications audits corrective actions and ensuring quality agreements are followed.
• Contribute to CAPA programs by logging events supporting root-cause investigations and helping implement corrective and preventive actions.
• Maintain document control systems ensuring version control archiving and inspection readiness per established SOPs.
• Assist with internal and external audits including documentation support tracking findings and coordinating follow-up actions.
• Support quality training maintain training records identify compliance gaps and ensure staff meet qualification requirements.
• Contribute to continuous improvement efforts by monitoring key quality metrics and assisting with SOP updates and regulatory compliance.

Core Qualifications & Experience :

Compensation : 60-75k base salary 10% annual bonus

Recruiter in Charge : Jeff Caskey

Managing Partner

Required Experience :

IC

Key Skills

Administrative Skills,Core Java,Glass,Administration Support,Database Administration,Import & Export

Employment Type : Full Time

Experience : years

Vacancy : 1