QC Microbiology Lead I (Pharmaceutical)

TL;DR

QC Microbiology Lead I (Pharmaceutical): Providing technical leadership for lab operations and ensuring high-quality microbiological testing in compliance with regulatory standards with an accent on validations, investigations, and GMP compliance. Focus on leading routine testing, overseeing lab equipment qualification, and resolving complex technical challenges in a pharmaceutical environment.

Location: Onsite in Irvine, California, United States

Salary: $30.00–$36.00 per hour

Company

A global leader in infusion therapy and pain management, developing innovative medical products and services for the healthcare industry.

What you will do

• Lead microbiological testing, including sample preparation, analysis, and documentation.
• Review and approve results to ensure compliance with methods and specifications.
• Plan and execute validations, including the development of protocols and reports.
• Lead and support investigations regarding CAPAs, deviations, OOS, and complaints.
• Oversee laboratory operations, including equipment qualification, calibration, and maintenance.
• Supervise day-to-day team work, assign tasks, and resolve escalated technical issues.

Requirements

• Must be based in or able to work onsite in Irvine, California
• Bachelor’s degree in a scientific field preferred (HS diploma required).
• 4+ years of experience in microbiology/QC within a regulated environment.
• Strong knowledge of microbiology methods, aseptic technique, and GMP.
• Experience with validations, investigations, and technical review.
• Strong leadership, problem-solving, and organizational skills.

Culture & Benefits

• Comprehensive healthcare package.
• 401(k) retirement plan.
• Tuition reimbursement.
• Commitment to a "Sharing Expertise" philosophy for continuous improvement.