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 day‑to‑day 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:
- Bachelor’s or associate degree in a life sciences field, or equivalent education/experience.
- 1+ years of quality, manufacturing, or regulatory experience within a regulated industry.
- Knowledge of GMP principles, regulatory frameworks, CAPA, deviations, and root-cause analysis.
- Strong attention to detail, organizational skills, and ability to clearly document technical/quality information.
- Proficient in MS Office, able to manage multiple tasks, and comfortable supporting vendor/CMO/3PL oversight; experience with contract manufacturing or audits is a plus.
Compensation: 60-75k base salary, 10% annual bonus
Recruiter in Charge: Jeff Caskey
Managing Partner – jeff@nexagensearch.com