Associate Engineer, Quality Assurance
Avid Bioservices · Tustin, California, US
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commer...
Job description
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Associate Engineer, Quality Assurance is an individual contributor who performs administrative tasks related to Avid's Change Management System and quality review of controlled documents in support product manufacturing and testing following cGMP regulations. Job Duties: - Author change control records for Quality Assurance team. - Author impact assessments, risk analyses, and change actions for Quality Assurance team. - Track change control records status by working closely with cross functional teams to ensure timely execution and on-time closure. - Participate in Change Control Review Board meeting and record minutes. - Work with senior engineers in the roll-out of new/changed systems to ensure effective and on-time implementation when necessary. - Collaborate with cross functional teams to ensure that reports and records review activities are executed efficiently and accurately per gover...