Associate Engineer, Quality Assurance

Avid Bioservices • Tustin, CA

9d • $26 - $33 • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• Experience in Quality Engineering is preferred.

Responsibilities

• 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.

Benefits

• We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
• Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 101-250 employees