Responsibilities:

• 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

Qualifications:

• 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