Metrology Manager

Our client is seeking a Metrology Manager that will be responsible for overseeing the day-to-day activities of laboratory operations and staffing including Metrology - Calibrations and Central Receiving Departments. This role will interpret, develop, and execute policies for the department/projects.

Responsibilities

• Manage technical employees ensuring priorities are communicated clearly; projects are completed on time, and compliance with protocols and overall objectives. Monitor sample receipt, testing, and sample/equipment release.
• Support R&D Laboratory from various departments in equipment allocation and sourcing evaluations. Ensure equipment is qualified, functioning properly, calibrated, and all associated documentation is in order.
• Lead the creation, review, approval, and execution of lab policies, procedures, and validations associated with Laboratory Operations Metrology-Calibrations and Central Receiving Teams. Lead teams in development, repair, trouble shooting of new and established test systems and equipment.
• Ensure documentation produced in lab is compliant with applicable cGMPs, GOPs, and GLPs. Review employee-produced documentation including research notebooks, forms, and logbooks. Ensure records are completed and monitored for accuracy, completeness, credibility, corrective action taken, analysis of records for impact to measure the effectiveness of the Calibration Services.
• Participates in audits by regulatory authorities (FDA, EU, ISO) and customers.
• Responsible for the safety of laboratory personnel/visitors. Manage laboratory housekeeping, inventory/sample receipt, and maintenance of equipment/instrumentation. Manage maintenance/qualification/calibration of R&D laboratory environmental control, utilities, and facility systems across multiple laboratory disciplines.
• Monitor and support 3rd party vendor service and calibration performance and provide support & Information to negotiate more favorable purchasing agreements.
• 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

• Bachelor's 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.
• Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines.
• 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).

Location

• Mundelein, IL

Employment Type

• W2 employee, contract and/or contract to hire

Benefits for W2 Employees

• Choice of medical, dental, and vision plans.
• Paid vacation time.
• Competitive hourly rate.
• 401(k)

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.

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