Quality Assurance Associate
2 weeks ago
Rockville, MD | Full-Time
Nexagen Searchis 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.
- 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
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