Supervisor, Quality Control

Avid Bioservices•Tustin, CA

7d•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 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.

Requirements

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

Nice To Haves

Experience in Project Management is desirable.

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.
Perform other duties as assigned.