2nd Shift Lab Supervisor - Quality & Compliance

Medline; 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 is seeking a Laboratory Supervisor to direct and coordinate the activities of lab technicians, ensuring compliance with FDA, ISO, and QSR requirements. You will mentor staff and engage with cross-functional teams to drive continuous improvement in testing of raw materials, in-process materials, and finished goods.

The role handles 2nd shift (3PM-11PM) and involves preparing staff for interactions with FDA, ISO registrar, vendors, suppliers, and customers.

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 with mentoring junior staff.
• Experience applying knowledge of laboratory quality systems & regulatory requirements (such as ISO 13485, 21 CFR Part 210/211 and QSR part 820).
• Technical writing experience in an FDA regulated industry.
• Position requires travel up to 10% of the time for business purposes.

Responsibilities

• Direct and coordinate the 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 SOPs, batch production records, quality records, and general documentation.
• Evaluate laboratory practices and processes for improvement opportunities while ensuring drug/device/cosmetic requirements are met; monitor training and qualification of laboratory technicians to ensure regulatory compliance.
• 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.
• Management responsibilities include: Direct daily activities and outcomes of a group of employees; Hiring staff, pay increases, performance reviews, training and development, budgeting.

Skills

Lab supervision

Regulatory compliance

Technical writing

Mentoring staff

Cross-functional liaison

Process improvement

Education

Bachelor's Degree in Chemistry, Microbiology, or Engineering

Job description

Medline Industries, LP is seeking a Laboratory Supervisor to direct and coordinate the activities of lab technicians, ensuring compliance with FDA, ISO, and QSR requirements. You will mentor staff and engage with cross-functional teams to drive continuous improvement in testing of raw materials, in-process materials, and finished goods.

The role handles 2nd shift (3PM-11PM) and involves preparing staff for interactions with FDA, ISO registrar, vendors, suppliers, and customers.