Senior Quality Associate

Stellenbeschreibung:

Support implementation, maintenance, and improvement of the Quality Management System
Support Contract Development and Manufacturing Organization (CDMO) and Contract Testing Lab (CTL) management
Author and review Standard Operating Procedures (SOPs)
Provide Quality Onboarding training
Support vendor management activities
Review and approve vendor documentation
Review executed manufacturing records in support of product disposition
Support computer system validation activities
Support quality performance and continuous improvement activities
Assist in compiling metrics for Quality Management Review
Perform other duties as assigned

Requirements

Bachelor's degree in Biology, Chemistry or other relevant scientific discipline preferred
4+ years of full-time cGMP Quality Assurance experience
Travel required up to 35%
Experience with eQMS (e.g., ACE, TrackWise)
Working knowledge of current industry practices and standards in an FDA-regulated biotechnology company
Excellent record keeping and documentation skills
Strong communication skills, both verbal and written, with the ability to concisely present information in cross-functional settings
Experience working with CDMOs preferred
Proficient use of MS Office products
Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and a great sense of urgency while ensuring that all cGMP and regulatory requirements are met
Ability to work effectively both independently and with other team members

Core Competencies

Demonstrates expertise in Quality Management Systems, cGMP Quality Assurance, and vendor management within FDA-regulated environments. Proficient in authoring SOPs, conducting quality training, and supporting continuous improvement initiatives.