Associate Specialist, Quality Assurance

Avid BioservicesTustin, CA
$52,800 - $66,000Onsite

About The Position

As an Associate Specialist, Quality Assurance, you will be a critical part of ensuring top-notch quality for our products and services. You will be responsible for various administrative tasks associated with Avid's electronic document management and training systems, issuing, and reconciling equipment logbooks and laboratory notebooks, and providing both formal and informal training to coworkers on relevant processes such as quality systems, training, and GMPs.

Requirements

  • B.A. or B.S. degree (preferably in Life Science).
  • Minimum of 1+ years of experience in the biopharmaceutical industry.
  • Knowledge of CGMPs or equivalent regulations.
  • Ability to interpret Quality standards for implementation.
  • Skills to independently evaluate situations and propose potential solutions.
  • "Bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
  • Exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
  • Master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Nice To Haves

  • Written and verbal skills are out of this world, and you communicate with clarity and confidence.

Responsibilities

  • Perform administrative tasks associated with Avid's electronic document management system.
  • Perform administrative tasks associated with Avid's electronic training system; this includes, but is not limited to, assigning curricula, generating training reports, creating/revising curricula.
  • Issue and reconcile equipment logbooks, laboratory notebooks, controlled documents (including but not limited to, SOPs, forms, and logs).
  • File documents in the QA archive; retrieve documents from the archive upon request.
  • Provide both formal and informal training to coworkers on relevant processes (including quality systems, training, and GMPs).
  • Provide assistance to customers in support of departmental functions including, but not limited to, document revisions, internal/external request for documents.
  • Collaborate with departments to ensure that all review activities are executed efficiently and effectively.
  • Participate in the design and implementation of department and cross-functional initiatives.
  • Enforce GMP requirements and QA policies, including Good Documentation Practices (GDP).
  • Provide support during regulatory and other inspections; maintain a state of inspection readiness.
  • Perform other duties as assigned by Quality management.

Benefits

  • health, dental, and vision insurance
  • 401(k) matching
  • paid time off
  • performance-based bonuses
  • opportunities for career growth and development
  • supportive and inclusive work environment
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