Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of clients and improve patient outcomes. The Associate Engineer, Quality Assurance will perform administrative tasks related to the Change Management System and quality review of controlled documents in support of product manufacturing and testing.
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 governing SOPs
Review and approve calibration reports and preventative maintenance records for manufacturing equipment, analytical instruments, facilities, and critical utilities
Author and revise quality system SOPs and forms
Provide support during regulatory inspections and other quality audits when necessary; maintain a state of inspection readiness
Notify Quality Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
Perform other duties as assigned by Quality Management
Qualification
Required
Bachelor of Science degree is required, either Biology, Chemistry, or Biochemistry
2+ years of experience in the pharmaceutical or biopharmaceutical industry
Knowledge of FDA cGMP regulations, ICH guidelines, and quality compliance requirements
Strong interpersonal skills with ability to work in a team environment
Flexibility in work hours to meet business objectives
Preferred
Experience in Quality Engineering is preferred
Benefits
Health, dental, and vision insurance
401(k) matching
Paid time off
Avid Bioservices' expansion will double existing capacity to service both a $40m backlog and its owner Peregrine.
