Specialist, Quality Assurance

Avid Bioservices•Tustin, CA

27d•Onsite

About The Position

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

Requirements

Bachelor’s degree (preferably in Life Science).
2+ 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 solution
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.

Responsibilities

Provide both formal and informal training to coworkers on relevant processes (including quality systems, training, and GMPs).
Perform administrative tasks associated with Avid's electronic Learning Management System.
Review controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product.
Track quality system records; send reminders to authors and approvers.
Review change requests and assist with discrepancy investigations.
Provide Quality oversight to internal and external customers.
Collaborate with departments to ensure that all review activities are executed efficiently and effectively.
Provide support during regulatory and other inspections; maintain a state of inspection readiness.