- Implements and maintains programs and processes to ensure high-quality products and compliance with cGMP and GLP.
- Primary areas of responsibility include QMS maintenance, Document Control and Document Changes, Trending, Production and R&D Internal Audits, Supplier Qualification and Complaints.
- Contributes to Training, DMR maintenance, tech transfer, batch disposition, labelling approval, deviation and NCR investigations, product and process changes and CMO oversight.
- Reviews manufacturing and equipment logs, and quality control data for in-process and finished products
- Supports inspection management and interacts closely with regulatory agencies.
- Oversees establishment of product specifications., writes and updates SOPs.
- Works extensively with cross-functional teams.
- May lead on investigations of deviations, nonconformances and complaints
- Bachelor of Science degree with 5+ years’ experience in Quality Assurance
- Knowledge of ISO 13485:2016, 14971:2012 and 21CFR 820.
- Excellent communication, documentation, and organizational skills
- A commitment to continual improvement
- Demonstrates knowledge of MS Office software
- Must have the ability to work effectively under high pressure with multiple deadlines