Extractable & Leachable Laboratory Manager
2 weeks ago
JOB SUMMARY
Working manager managing daily Extractable & Leachable laboratory operations and staff at Medline Analytical Lab to support client submissions . Interpret, develop, and execute policies for department/projects. Hire, train, and develop staff; recommend pay increases, conduct performance reviews, and may have limited budgetary responsibility. Lab Manager must have experience operating LC-MS, GC-MS, and ICP-MS systems for analysis of volatile, semi-volatile, non-volatile organic, and heavy metals from medical devise samples .
MAJOR RESPONSIBILITIES
Analysis of sample extract solutions by GC-MS, LC-MS, and ICP-MS to adequately resolve and identify all compounds
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. Develop analysis methods for medical device drug product leachable testing
Ensure documentation produced in lab is compliant with applicable cGMPs, GOPs, and GLPs. Review employee-produced documentation including research notebooks, forms, and logbooks.
Serves as a study director for E&L studies, including drafting protocols and assembling data into final reports. 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. QualificationsMINIMUM JOB REQUIREMENTS
Education
Bachelor's degree in Microbiology, Biology, Engineering or Chemistry.
Work Experience
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 presenting data to leadership.
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 ( senior management and non-technical audiences).
Position requires up to 10% trave l
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