Quality Assurance Specialist

POSITION SUMMARY:

The Quality Assurance Specialist provides support to the Quality Assurance Department by performing functions which aid assurance of GxP compliance. The Quality Assurance Specialist is responsible for assuring that operations are performed according to written SOPs, GxPs, and FDA guidelines.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

•Conduct internal audits, generate reports, and track corrective actions
•Track Implementation Planning Task
•Review manufacturing BR, QC release, EM data, etc.
•Initiate failure investigations, track progress and closeout; track, investigate, and close complaints
•Initiate, track, and close corrective actions and preventive actions
•Conduct GxP training and new employee training
•Create new SOPs and review draft SOPs, work instructions, etc., for compliance with Aeras and FDA requirements
•Coordinate contract calibration activities
•Other duties as assigned
REQUIREMENTS
QUALIFICATIONS AND REQUIREMENTS:

•Bachelor of Sciences degree and three+ years of experience in a Quality Assurance role within a GxP environment
•Must have hands-on experience in some of the following areas: internal audits, change control procedures, lot release, failure investigations, complaints, CAPA Program, deviation systems, GxP and new employee training, supplier qualification, document control, trending, QA presence on manufacturing floor, and equipment calibration and maintenance program
•Good understanding of FDA regulations (biologics or drugs)
•Detail-oriented with good verbal and written communications skills; demonstrated ability to manage multiple projects/tasks
•Ability to analyze data for accuracy and correctly interpret results
•Microsoft Office experience