Lab Manager- Calibration

1 week ago

Mundelein, United States Medline Industries - Transportation & Operations Full time

Job Summary

Manage daily laboratory operations and staff including (Metrology - Calibrations & Centeral Receiving Departments). 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.

Job Description

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-Calbrations 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.

  • 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:
  • 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 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.

  • Knowledge / Skills / Abilities

  • 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).


Benefits

  • Medline is committed to offering competitive benefits and a variety of choices to best meet the needs of you and your family. For employees scheduled to work at least 30 hours per week, this includes health and well-being, financial fitness, career development, paid time off and more. Employees scheduled to work less than 30 hours per week can participate in the 401(k) plan, access the Employee Assistance Program (EAP), Employee Resource Groups (ERG) and Medline Service Corps. For a more comprehensive list of our benefits, please click
here

Every day, we’re focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what’s right to delivering business results, together, we’re better. Explore our Diversity, Equity and Inclusion page here

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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