Metrology Specialist
2 weeks ago
Location: New Brunswick NJ 08903
Duration: 12 months
Comments:
Must Haves:
- calibration, maintenance, repair, and performance verification work.
- Oversee vendors during work execution and need experience in GMP environment.
Job Description:
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.
Additional Job Requirements:
- None
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