QC Laboratory Lead

QC Laboratory Lead Position Summary

We are seeking a QC Laboratory Lead to provide front-line leadership within a GMP-regulated Quality Control laboratory. This role is ideal for an experienced QC professional who enjoys balancing operational leadership with hands-on laboratory support.

The QC Laboratory Lead will oversee daily testing operations, coordinate laboratory schedules and priorities, provide technical guidance, and ensure testing activities are completed safely, accurately, and on time. Acting as the primary point of contact for day-to-day laboratory operations, this individual will play a critical role in supporting manufacturing timelines, product release activities, and overall laboratory performance.

This position is approximately 80% operational leadership and coordination and 20% hands-on laboratory support.

Key Responsibilities Laboratory Operations & Leadership

+ Lead day-to-day operations within a GMP Quality Control laboratory.

+ Develop, manage, and optimize testing schedules to support manufacturing and product release timelines.

+ Coordinate daily testing priorities across QC Analysts and Chemists.

+ Monitor workflow, resource allocation, and schedule adherence to ensure on-time execution.

+ Serve as the primary operational resource for frontline laboratory personnel.

+ Promote accountability, responsiveness, and operational excellence across the team.

+ Coach and mentor analysts while fostering a collaborative and high-performing laboratory environment.

+ Approve timecards and assist with staffing and scheduling activities.

Technical Oversight

+ Review analytical data and laboratory documentation for accuracy, completeness, and compliance.

+ Provide troubleshooting support for analytical methods and testing activities.

+ Support investigations, deviations, and laboratory issue resolution.

+ Partner with external contract testing laboratories to ensure timely execution and data delivery.

+ Assist with analytical method validation and implementation activities.

+ Provide technical guidance related to HPLC and other analytical methodologies.

Quality & Compliance

+ Ensure compliance with cGMP regulations, SOPs, data integrity requirements, and quality systems.

+ Support product release activities through data review and documentation oversight.

+ Collaborate with QA, Manufacturing, and cross-functional teams to meet business objectives.

+ Drive continuous improvement initiatives and laboratory efficiency programs, including Lean, 5S, and Kanban principles.

Required Qualifications

+ Bachelor's degree in Chemistry, Biochemistry, or a related scientific discipline.

+ 4+ years of experience in a GMP-regulated Quality Control laboratory.

+ Demonstrated experience supporting analytical testing, investigations, documentation review, and product release activities.

+ At least 1 year of leadership, team lead, or technical leadership experience.

+ Hands-on experience with HPLC in a regulated laboratory environment.

+ Strong understanding of cGMP regulations, quality systems, and data integrity principles.

+ Ability to influence and lead teams without direct reporting authority.

+ Strong organizational, prioritization, and problem-solving skills.

+ Experience mentoring or developing laboratory personnel.

+ Excellent communication and cross-functional collaboration skills.

Preferred Qualifications

+

Experience with in pharmaceutical, biotech, peptide, or biologics manufacturing environments.

+ Working knowledge of:

+ Mass Spectrometry

+ Gas Chromatography (GC)

+ Moisture Analysis

+ Experience supporting analytical method validation activities.

+ Experience conducting laboratory investigations and technical troubleshooting.

+ Familiarity with outsourced or contract testing laboratory management.

+ Exposure to Lean…