Supervisor, Quality Control

avidbio; Tustin (CA); On-site; USD 86,400 - 108,000; Full time

Job summary

Avid Bioservices in California is seeking a Quality Control Supervisor to lead the External Testing Group, directing day-to-day QC operations, ensuring cGMP compliance and timely testing, reporting, and client interactions.

You will manage staff, review methods, coordinate shipments, maintain documentation, and drive continuous improvement across QA activities while partnering with cross-functional teams in product development, manufacturing, and quality assurance.

Qualifications

• BS degree in a scientific discipline with 1 year in QC/analytical lab and 1 year supervisory experience.
• Experience with writing reports/procedures/specifications, GMPs and regulatory audits.
• Familiarity with the drug development process is required.

Responsibilities

• Plan, supervise, and coordinate external and internal testing activities.
• Review and approve purchase requests, invoices, and sample submission forms.
• Maintain and track shipping/testing due dates for lot release, stability, and project samples.
• Attend and lead weekly contract lab meetings and provide status updates to clients.

Skills

Report writing

GMP knowledge

Supervisory experience

Regulatory audits

Education

BS degree in a scientific discipline

Job description

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 Supervisor provides leadership and oversees the day-to-day operations of the Quality Control External Testing Group. They will plan, direct and coordinate internal and external activities ensuring organizational and departmental goals and objectives are met. He or She will supervise the performance and development of direct reports and will lead and support continuous improvement initiatives. This role blends technical expertise with supervisory and client engagement responsibilities.

Key Responsibilities:

• Plan, coordinate and supervise external and internal testing and support activities.
• Initiate, review, and approve purchase requests and invoices.
• Initiate and review contract laboratory sample submission forms.
• Maintain and track shipping and testing due dates for lot release, stability, and project samples.
• Track final report due dates and download data from contract laboratory sites.
• Attend and manage weekly contract laboratory meetings and provide status updates to required departments and clients.
• Attend client meetings.
• Coordinate and manage inventory, sample disposition and annual retention inventory.
• Coordinate test method form review.
• Manage and review temperature monitoring.
• Oversee VMI
• Ensure labs remain in 5S state including waste disposal, glassware wash and other lab support activities are completed per schedule.
• Monitor progress of individuals and teams toward departmental goals.
• Supervise analysts in their work assignments and identify needs for further training.
• Ensure adherence to regulatory compliance and cGMPs.
• Provide review and feedback including evaluations, and ensure correct billing of time and materials to clients.
• Approve timesheets of reports.
• Facilitate or coordinate training for QC personnel in areas of regulations and compliance.
• Ensure thorough and proper documentation of activities.
• Lead or designate a lead for investigations related to out of specifications and out of tolerance results.
• Interact with internal customers from cross-functional groups such as product development, analytical development, manufacturing, quality assurance to ensure adequate QC support for those groups.
• Responsible for thorough knowledge of cGMP and regulatory requirements and ensure compliance.
• Directs activities of functional areas through direct reports.
• Minimal overnight travel by land and/or air may be required.
• Perform other duties as assigned.

Minimum Qualifications:

• B.S. degree in a scientific discipline and preferably a minimum of 1 year of life science industry experience in a QC or analytical lab including 1 year of supervisory experience.
• Experience with writing reports/procedures/specifications, GMPs and regulatory audits.Familiarity with drug development process is required.
• Experience in Project Management is desirable.

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.

The compensation range for this role is $86,400 - $108,000 annually 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.