Specialist, Quality Control

Avid Bioservices•Tustin, CA

4d•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 Control Specialist is an individual contributor who works within the QC Stability team. Dedicated to supporting cross-functional teams and driving continuous improvement within the stability program to maintain high standards of quality and regulatory readiness.

Requirements

Exceptional multitasking skills
Unparalleled attention to detail
Mastery at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Visual acuity, including close, distance, and color vision

Nice To Haves

"Bring it on!" team player approach
Unshakable positive attitude
Exceptional written and verbal skills, communicating with clarity and confidence.

Responsibilities

Assist in stability sample pulls at each timepoint
Oversee proper storage, handling, and inventory of stability samples in temperature-controlled chambers
Prepare/aliquot R&D stability samples
Assist in Reference Standard Generation activities
Generate weekly stability status reports for management using Excel
Independently manage competing priorities with limited instruction
Collaborate with management to establish and meet targets and timelines by providing weekly forecasts
Identify and recommend solutions to potential procedure, process and system gaps
Maintain and track stability QC testing documentation (STWs and QC test method forms)
Review documentation from the QCA, QCM departments and 3rd party vendors
Compile data for Stability Summary of Testing reports (SofT’s)
Prepare Stability Summary of Testing reports, Certificates of Analysis, and Statements of Testing
Identify opportunities to optimize stability workflows and contribute to process improvement initiatives
Support internal and external audits
Perform other duties as requested by management to support quality activities
Maintain the quality compliance of all QC operational areas
Ensure and apply GMP throughout operations
Prepare – STW/LIMS/label generation
Aliquot – sterile aliquoting of samples into assay specific individually labeled tubes
Ship/Track – track samples weekly to maintain on-time target delivery
Dispose – coordinate sample inventory and disposition