Quality Control Supervisor

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

Benefits offered by this job

Health, Dental, and Vision Insurance

401(k) Matching

Paid Time Off

Job summary

BioTalent in the United States is seeking a Quality Control Supervisor to lead day-to-day QC operations in a fast-paced biopharmaceutical laboratory. You will manage external testing programs, oversee lot release, stability and project sample testing, and collaborate with manufacturing, QA, and clients.

The ideal candidate holds a B.S. in a scientific field with at least two years in life sciences and one year in a supervisory role, plus experience writing reports, SOPs, GMPs, and preparing for

Qualifications

• B.S. degree in a scientific discipline and a minimum of 2 years of life science industry experience in a QC or analytical lab including 1 year of supervisory experience.
• Must have experience with writing reports, procedures, specifications, GMPs, and regulatory audits. Familiarity with the drug development process is required.
• Hands-on experience or exposure with: Quality Control, Lot Release Testing, Stability Programs, OOS Investigations, Training and Mentoring.

Responsibilities

• Lead and supervise day-to-day Quality Control operations and external testing activities
• Coordinate lot release, stability, and project sample testing
• Support contract laboratory management, sample submissions, and testing schedules
• Review and approve purchase requests, invoices, and laboratory documentation
• Manage inventory, sample disposition, retention programs, and laboratory support functions
• Monitor departmental performance and support achievement of business objectives
• Train, mentor, and develop Quality Control personnel
• Collaborate with Manufacturing, Quality Assurance, Analytical Development, Product Development, and external clients
• Lead investigations involving OOS and OOT results
• Support cGMP compliance, regulatory readiness, and continuous improvement initiatives

Skills

Quality Control

Lot Release Testing

Stability Programs

OOS Investigations

Training and Mentoring

Education

Bachelor's degree in a scientific discipline

Job description

Help Ensure Quality in Life-Saving Biopharmaceuticals

Are you passionate about Quality Control, laboratory operations, team leadership, and GMP compliance? We’re looking for a Quality Control (QC) Supervisor to join a growing biopharmaceutical team supporting innovative biologic therapies.

If you thrive in a fast-paced QC laboratory environment and enjoy leading teams, managing external testing programs, and collaborating with clients and cross-functional groups, this could be your next opportunity.

What You'll Do

• Lead and supervise day-to-day Quality Control operations and external testing activities


• Coordinate lot release, stability, and project sample testing activities


• Support contract laboratory management, sample submissions, and testing schedules


• Review and approve purchase requests, invoices, and laboratory documentation


• Manage inventory, sample disposition, retention programs, and laboratory support functions


• Monitor departmental performance and support achievement of business objectives


• Train, mentor, and develop Quality Control personnel


• Collaborate with Manufacturing, Quality Assurance, Analytical Development, Product Development, and external clients


• Lead investigations involving out-of-specification (OOS) and out-of-tolerance (OOT) results


• Support cGMP compliance, regulatory readiness, and continuous improvement initiatives

What We're Looking For

• B.S. degree in a scientific discipline and a minimum of 2 years of life science industry experience in a QC or analytical lab including 1 year of supervisory experience


• Must have experience with writing reports, procedures, specifications, GMPs, and regulatory audits. Familiarity with the drug development process is required.


• Hands-on experience or exposure with:

• Quality Control


• Lot Release Testing


• Stability Programs


• OOS Investigations


• Training and Mentoring

Bonus

• Experience in Project Management is desirable.

$86,400 – $108,000 annually (depending on experience and qualifications)

Benefits

• Health, Dental, and Vision Insurance


• 401(k) Matching


• Paid Time Off

Please Note

• On-site in Tustin, CA


• Overtime and weekend availability may be required


• Applicants must already be authorized to work in the U.S.