Associate Engineer, Quality Assurance

United States·Tustinmid

OtherQuality Assurance

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Quick Summary

Overview

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.

Key Responsibilities

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…

Requirements Summary

Experience in Quality Engineering is preferred. Position Type/Expected Hours of Work: This role is a full-time onsite position. Days of work are Monday through Friday, 8:00am to 5:00pm, unless otherwise stated by Supervisor.

Technical Tools

OtherQuality Assurance

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 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.

Minimum Qualifications:

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 Qualifications:

Experience in Quality Engineering is preferred.

Position Type/Expected Hours of Work:

This role is a full-time onsite position. Days of work are Monday through Friday, 8:00am to 5:00pm, unless otherwise stated by Supervisor. The employee must also, if instructed, have the ability to work overtime and/or weekends when necessary.

Compensation:

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.

The compensation range for this role is $26.15 to $32.69 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.