Specialist, Quality Control

avidbio; Tustin (CA); On-site; USD 44,083 - 55,104; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices in California (Tustin) is seeking a Quality Control Specialist to join the QC Stability team as an individual contributor focused on maintaining regulatory readiness and continuous improvement within the stability program.

You will handle stability sample pulls, storage, QC testing documentation, weekly reports, audits, and collaboration with QCA/QCM and vendors, while upholding GMP and meeting timelines.

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
• Generate weekly stability status reports for management using Excel
• Maintain and track stability QC testing documentation (STWs and QC test method forms)
• Review documentation from the QCA, QCM departments and 3rd party vendors
• 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

Skills

Team player

Communication

multitasking

Job description

Your Role:

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 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.

Key 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

QC Stability Sample Lifecycle Maintenance:

• 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

Position Type/Expected Hours of Work:

This role is a full-time onsite position. Days and hours of work are Monday through Friday unless otherwise stated by Supervisor. The employee must also 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.

• health, dental, and vision insurance, 401(k) matching, and paid time off

The compensation range for this role is $32.30 - $40.38 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.