Associate Specialist, Quality Assurance

Avid Bioservices•Tustin, CA

5d•$28 - $31

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 Quality Assurance Associate Specialist is an individual contributor who solves a variety of issues following cGMP regulations and company standards.

Requirements

Knowledge of cGMPs or equivalent regulations.
Ability to interpret Quality standards for implementation.
Skills to independently evaluate situations and propose potential solutions.

Nice To Haves

B.A. or B.S. degree (preferably in Life Science).
Minimum of 1 -3 years of experience in the biopharmaceutical industry.

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.