Senior QA Operations Lead — Sterile Pharma (2nd Shift)

Alliance Medical Products, Inc.; Irvine (CA); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, vision

401K

Paid time off

Sick & personal leave

Holidays

Job summary

Siegfried in Irvine, CA is seeking a QA Operations Supervisor, 2nd Shift, to lead a team of QA professionals supporting sterile and aseptic manufacturing, providing real-time quality oversight on the production floor and ensuring cGMP compliance.

You will collaborate with Manufacturing, Validation, Engineering and Microbiology, coach staff, drive continuous improvement, and serve as the primary quality leader during the shift.

Qualifications

• Bachelor's degree in Biology, Chemistry, Biochemistry, Engineering, or related scientific discipline.
• 4–6 years of experience in Quality Assurance/Quality Operations or GMP manufacturing.
• Demonstrated supervisory or people leadership experience.
• Strong understanding of cGMP requirements and FDA regulations.

Responsibilities

• Lead, mentor, and develop a QA team on second shift.
• Provide real-time quality oversight of formulation, filling, and packaging operations.
• Ensure compliance with cGMP, SOPs, and data integrity principles on the production floor.
• Support investigations, deviations, CAPAs, and root cause analyses.

Skills

Supervisory experience

Team leadership

Quality mindset

Problem solving

Education

Bachelor's degree in Biology, Chemistry, Biochemistry, Engineering, or related scientific discipline

Tools

TrackWise

SAP

LIMS

Job description

Siegfried in Irvine, CA is seeking a QA Operations Supervisor, 2nd Shift, to lead a team of QA professionals supporting sterile and aseptic manufacturing, providing real-time quality oversight on the production floor and ensuring cGMP compliance.

You will collaborate with Manufacturing, Validation, Engineering and Microbiology, coach staff, drive continuous improvement, and serve as the primary quality leader during the shift.