Quality - Laboratory Instrumentation Support Tech

Laboratory Instrumentation Support

New Brunswick, NJ

This position is 100% Onsite

Work Schedule:

Mon - Fri, Business Hours

Responsible for:

• Reviews and approves vendor executed calibration, maintenance, repair, and performance verification work.
• Prepare documentation for approval by Quality Assurance prior to execution of work.
• Monitors schedules and ensures that calibration, performance verification testing, and maintenance services completed on time.
• Conducts calibration testing on laboratory equipment according to protocol or procedure.
• Oversees vendors during execution of work, ensure safety and compliance practices are followed.
• Immediately reports deviations and discrepancies in testing, compliance and safety practices, and documentation.
• Proposes and implements corrective actions.
• Ensures after vendor work completions that instrument is ready to use.
• Collaborates with the quality unit to ensure completeness and accuracy of submitted documentation, as well as addressing/resolving compliance concerns to GMP regulatory standards.
• Provides input during the review of procedures for calibration, preventative maintenance, and performance verification of equipment.
• Regularly reviews, prioritizes, and promptly responds to customer equipment performance verification and support requests.
• Interacts effectively with laboratory, Quality Assurance, and other departments, as required.
• Interfaces with customers to ensure all expectations are met.

Qualifications:

• The qualified individual must have 4 - 7 years of relevant laboratory instrument/equipment calibration and performance verification testing experience in a regulated environment.
• Bachelor or technical certificate a plus.
• Understands 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)
• Must be detail oriented, well organized with clear communication in speech and writing.
• Works well independently and in a team, driving projects to completion with minimal oversight.
• Must have customer focused attitude and able to work with urgency to meet the assigned timelines.
• Must have experience and skill at reviews for data accuracy and compliance of tests to specifications.
• Commitment to accuracy and truthfulness in all activities.
• Must have ability to interact and accurately communicate the information with appropriate team members, co-workers, and customers.
• Must be self-motivated and driven to move the project to completion.
• Routine user of Microsoft Office Suite-Word, Excel, PowerPoint and Outlook.