at Medline Industries, Inc. in Mundelein, Illinois, United States
Job Description
Job Summary
Responsible for managing daily laboratory operations and staff (Chemistry, Microbiology, or Material Science)
Job Description
Responsibilities:
- Manage day to day activities.
- Ensure priorities and objectives are communicated clearly; projects are completed on time, and compliance with protocols and overall objectives.
- Overall responsibility for sample receipt and testing of materials assigned. Ensure equipment in their area is functioning properly calibrated, and all associated documentation is in order.
- Lead the creation, review, approval, and execution of lab policies, procedures, and method validations.
- Ensure documentation produced in lab is compliant with applicable cGMPs, GOPs, and GLPs.
- Review employee-produced documentation including research notebooks, forms, and logbooks.
- Prepares for and participates in internal and external audits by regulatory authorities (FDA, EU) and customers.
- Responsible for the safety of laboratory personnel/visitors.
- Manage laboratory housekeeping and maintenance of non-calibrated equipment/instrumentation.
- Fosters and maintains positive relationships with internal and external colleagues ensuring timely and accurate communication.
- Management responsibilities include: -
- Typically oversees professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environments
- Day-to-day operations of a group of employees.
- May have limited budgetary responsibility and usually contributes to budgetary impact
- Interpret and execute policies for departments/projects and develops. Recommend and implement new policies or modifications to existing policies. Provide general guidelines and parameters for staff functioning.
- Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.
Qualifications:
- Education Bachelors degree in Microbiology, Biology, Engineering or Chemistry. At least 4 years of pharmaceutical, medical device or cosmetic GMP laboratory experience.
- Experience assessing and initiating actions independently and acting as project manager.
- Experience using time management skills such as prioritizing, organizing, and tracking details.
- Experience applying knowledge of ISO 17025 and CFR requirements; experience interacting with FDA/ISO auditors.
- Experience applying knowledge and experience working with USP/ASTM/ISO/AAMI/etc test methods.
- Experience applying knowledge of FDA requirements and experience with FDA interactions as part of drug and/or device regulatory approval process Additional Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines.
- Technical writing skill and ability.
- Skill and ability to diagnose, isolate, and resolve complex issues and recommend and implement strategies to resolve problems.
- Requires the ability to present and communicate with various audiences (e.g. senior management and non-technical audiences).
Position requires up to 10% travel
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity
