Senior Lab Supervisor – FDA/ISO Compliance, 2nd Shift

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

Job summary

Medline Industries seeks a Lab Supervisor to direct and coordinate the activities of lab technicians performing chemical and microbiological testing of raw materials, in-process materials and finished goods. You will ensure FDA/ISO/ICH compliance and prepare staff to engage with regulators and customers.

The role involves mentoring staff, improving laboratory practices, and developing SOPs while maintaining GMP expectations.

Qualifications

• Bachelor’s degree in Chemistry, Microbiology, or Engineering.
• At least 3 years of lab experience in the Medical Drug/Device Industry.
• Experience applying knowledge of laboratory quality systems & regulatory requirements (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 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.
• 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.
• 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.

Skills

Mentoring junior staff

Technical writing

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor’s degree in Chemistry, Microbiology or Engineering

Job description

Medline Industries seeks a Lab Supervisor to direct and coordinate the activities of lab technicians performing chemical and microbiological testing of raw materials, in-process materials and finished goods. You will ensure FDA/ISO/ICH compliance and prepare staff to engage with regulators and customers.

The role involves mentoring staff, improving laboratory practices, and developing SOPs while maintaining GMP expectations.