2nd Shift Lab Supervisor – Quality & Regulatory Lead

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

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Mundelein, IL seeks a Laboratory Supervisor to direct and coordinate lab technicians performing chemical and microbiological testing of materials and finished goods. You will ensure compliance with FDA and ISO requirements, mentor staff, and prepare for interactions with regulators and customers.

The role emphasizes developing procedures, writing reports, and driving continuous improvement across laboratory processes while managing the 2nd shift (3 PM–11 PM).

Qualifications

• Bachelor’s Degree in a technical discipline such as Chemistry, Microbiology, Engineering.
• 3+ years of lab experience in Medical Drug/Device Industry; mentoring junior staff.
• Experience applying laboratory quality systems & regulatory requirements (ISO 13485, 21 CFR Part 210/211, QSR 820).
• Technical writing experience in an FDA regulated industry.

Responsibilities

• Direct and coordinate activities of lab technicians including chemical and microbiological testing of raw materials, in process materials, finished goods, stability and project support as assigned.
• Confer with other supervisors to coordinate operations and activities within or between departments.
• Serve as a 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 any quality concerns throughout facility.
• Write or review technical reports or documentation such as deviation reports, testing protocols, and trend analyses.
• Develop or update procedures, policies, or standards.
• Write and review SOP’s, batch production records, quality records, and general documentation.
• Research, compile, and prepare reports, manuals, correspondence, or other information required by management or governmental agencies.
• Evaluate laboratory practices and process for improvement opportunities while ensuring drug/device/cosmetic requirements are met.
• Monitor training and qualification of laboratory technicians to ensure compliance to SOPs and regulatory requirements.
• Evaluate laboratory processes and cross-functional interactions for continuous improvement opportunities.
• Assist Quality Department interfacing with FDA, ISO registrar, vendors, suppliers, and customers as it relates to Laboratory and Good Manufacturing Practices including responding with corrective/preventive actions when non-conformances are found.

Skills

Lab supervision

Mentoring staff

Regulatory knowledge

Technical writing

Education

Bachelor's Degree in Chemistry / Microbiology / Engineering

Job description

Medline Industries, LP in Mundelein, IL seeks a Laboratory Supervisor to direct and coordinate lab technicians performing chemical and microbiological testing of materials and finished goods. You will ensure compliance with FDA and ISO requirements, mentor staff, and prepare for interactions with regulators and customers.

The role emphasizes developing procedures, writing reports, and driving continuous improvement across laboratory processes while managing the 2nd shift (3 PM–11 PM).