Senior Laboratory Operations & Compliance Manager

Socket.dev; Chicago (IL); On-site; USD 110,000 - 130,000; Full time

Job summary

Nemera seeks a Lab Manager to oversee daily lab operations, ensure safety, and maintain compliance with regulatory standards. You will supervise personnel, manage equipment and inventory, and support projects through high-quality operations.

Ideal candidates have extensive experience in regulated labs, strong leadership, and hands-on expertise with QA tools and laboratory systems. The role emphasizes coordinating testing, documentation, and process improvements in a fast-paced environment.

Qualifications

• Bachelor's or master's degree in engineering, science, or a related field.
• 7–10+ years in a regulated pharmaceutical or medical device lab.
• 3+ years in lab operations and people management.
• Experience with quality tools such as MSA, Gage R&R and DOE.
• Excellent interpersonal and organizational skills.
• Experience with laboratory information management systems (LIMS).
• Experience with mechanical testing.

Responsibilities

• Maintains data integrity and ensures compliance with FDA, cGxP, and QSR.
• Performs reviews of test data and documentation practices.
• Ensures calibration and maintenance of laboratory equipment.
• Selects and orders new equipment and tools as necessary.
• Performs testing to meet project schedules.
• Enforces the application of laboratory rules and procedures.
• Leads and organizes all laboratory activities including planning, organizing of work and reporting.
• Deploys EH&S policies to prevent accidents and manage waste.
• Implements quality policies to ensure regulatory compliance.
• Uses laboratory instrumentation and computer systems to collect and record data.

Skills

Leadership

Data integrity

Regulatory compliance

Lab testing

Calibration

Gage R&R

DOE

Documentation

Safety compliance

Communication

Education

Bachelor’s or Master’s degree in Engineering, Science or related field

Tools

LIMS

DOE

Gage R&R

Job description

Nemera seeks a Lab Manager to oversee daily lab operations, ensure safety, and maintain compliance with regulatory standards. You will supervise personnel, manage equipment and inventory, and support projects through high-quality operations.

Ideal candidates have extensive experience in regulated labs, strong leadership, and hands-on expertise with QA tools and laboratory systems. The role emphasizes coordinating testing, documentation, and process improvements in a fast-paced environment.