Quality Assurance Associate

Rockville, MD - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Quality Assurance Associate

Rockville MD Full-Time

Nexagen Searchis representing a biotechnology company that is hiring for anQuality Assurance Assocuateto 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:

Bachelors 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

Required Experience:

Quality Assurance Associate Rockville MD Full-Time Nexagen Searchis representing a biotechnology company that is hiring for anQuality Assurance Assocuateto join their team in Rockville MD. This role will support the Quality Director by executing daytoday quality operations ensuring documentation i...