100% onsite
Responsibilities:
• Review and approve vendor-executed calibration, maintenance, repair, and performance verification work.
• Prepare documentation for Quality Assurance approval prior to work execution.
• Monitor schedules to ensure timely completion of calibration, performance verification testing, and maintenance services.
• Ensure calibration testing on laboratory equipment follows established protocols.
• Oversee vendors during work execution, ensuring adherence to safety and compliance practices.
• Immediately report any deviations, discrepancies, or safety concerns and propose/implement corrective actions.
• Ensure instruments are ready for use after vendor work completion.
• Collaborate with the quality unit to ensure accuracy and completeness of documentation and address compliance concerns to meet GMP regulatory standards.
• Regularly review and prioritize customer equipment performance verification and support requests, responding promptly.
• Interact effectively with laboratory, Quality Assurance, and other departments as necessary.
• Interface with customers to ensure their expectations are met.
Qualifications:
• 2-5 years of relevant experience in calibrating and performing verification tests on laboratory instruments/equipment in a GMP regulated environment.
• Associate or Bachelor's degree
• Familiarity with the use of balances, pipettes, and HPLCs in the laboratory.
• Demonstrated work experience in compliance with cGMP and FDA requirements, including Good Documentation Practices (GDP).
• Detail-oriented and well-organized with excellent communication skills in both verbal and written forms.
• Ability to work independently and collaboratively in a team, ensuring project completion with minimal supervision.
• Customer-focused attitude with a sense of urgency to meet assigned timelines.
• Experience in reviewing data for accuracy and compliance with specifications.
• Strong commitment to accuracy and truthfulness in all activities.
• Ability to effectively interact and communicate information with team members, co-workers, and customers.
• Self-motivated and driven to see projects through to completion.
• Routine user of Microsoft Office Suite, including Word, Excel, PowerPoint and Outlook.