2nd Shift Lab Supervisor - Quality, Compliance & Leadership

Medline Industries, LP; Mundelein (IL); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Laboratory Manager to direct and coordinate the activities of lab technicians across chemical and microbiological testing, ensuring compliance with FDA and ISO requirements. You will develop staff understanding of regulatory expectations and engage with FDA/ISO registrar, vendors, and customers as needed.

The role emphasizes continuous improvement of laboratory processes, technical report writing, SOP development, and cross-functional collaboration to support

Qualifications

• Education: Bachelor’s Degree in a technical discipline such as Chemistry, Microbiology, Engineering.
• Work Experience: At least 3 years of lab experience in Medical Drug/Device Industry with mentoring junior staff.
• Knowledge: familiarity with regulatory requirements (ISO 13485, 21 CFR Part 210/211 and QSR 820).
• Technical writing experience in a regulated industry.

Responsibilities

• Direct and coordinate activities of lab technicians including chemical and microbiological testing.
• Confer with supervisors to coordinate operations across departments.
• Serve as technical liaison between quality control and other departments, vendors, or contractors.
• Participate in out-of-specification and failure investigations and recommend corrective actions.
• Assist in troubleshooting quality concerns throughout facility.
• Write or review technical reports, deviation reports, testing protocols, and trend analyses.
• Develop or update procedures, policies, or standards; write/review SOPs and batch records.
• Prepare reports and documentation for management or governmental agencies.
• Evaluate laboratory practices for continuous improvement while ensuring regulatory requirements are met.
• Monitor training and qualification of laboratory staff for SOP compliance.
• Interfacing with FDA, ISO registrar, vendors, suppliers, and customers on regulatory matters.

Skills

Lab supervision

Regulatory knowledge

Technical writing

Leadership

Mentoring

Education

Bachelor’s Degree in Chemistry / Microbiology / Engineering

Job description

Medline Industries, LP is seeking a Laboratory Manager to direct and coordinate the activities of lab technicians across chemical and microbiological testing, ensuring compliance with FDA and ISO requirements. You will develop staff understanding of regulatory expectations and engage with FDA/ISO registrar, vendors, and customers as needed.

The role emphasizes continuous improvement of laboratory processes, technical report writing, SOP development, and cross-functional collaboration to support