Lab Supervisor: FDA/ISO Compliance, 2nd Shift

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

Job summary

Medline Industries, LP seeks a Laboratory Supervisor to lead lab staff in chemical and microbiological testing of materials and products. Emphasis on FDA/ISO/ICH compliance, mentoring, and cross-functional collaboration. Includes preparing reports and interfacing with regulators, vendors, and customers.

2nd shift: 3PM-11PM. Responsibilities include ensuring regulatory adherence, developing SOPs, and managing staff performance while supporting continuous improvement initiatives.

Qualifications

• Bachelor’s Degree in a technical discipline such as Chemistry, Microbiology, Engineering.
• At least 3 years of lab experience in the Medical Drug/Device Industry.
• Experience applying knowledge of laboratory quality systems & regulatory requirements (e.g., ISO 13485, 21 CFR Part 210/211 and QSR Part 820).
• Technical writing experience in an FDA-regulated industry.

Responsibilities

• Direct and coordinate the activities of lab technicians performing chemical and microbiological testing of materials and finished goods.
• Confer with supervisors to coordinate operations; serve as 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.
• Write or review technical reports, SOPs, batch records, and related documentation; develop procedures and manuals.

Skills

Lab supervision

Mentoring

Regulatory knowledge

Technical writing

Cross-functional liaison

Education

Bachelor’s Degree in chemistry/microbiology/engineering

Job description

Medline Industries, LP seeks a Laboratory Supervisor to lead lab staff in chemical and microbiological testing of materials and products. Emphasis on FDA/ISO/ICH compliance, mentoring, and cross-functional collaboration. Includes preparing reports and interfacing with regulators, vendors, and customers.

2nd shift: 3PM-11PM. Responsibilities include ensuring regulatory adherence, developing SOPs, and managing staff performance while supporting continuous improvement initiatives.