Laboratory Technical Associate
Durham, United States
Job Description
JOB OVERVIEW
The Senior Metrology Specialist will be responsible for proactively ensuring equipment and instrumentation meet compliance and business requirements.
ESSENTIAL FUNCTIONS
• Responsible for installation and qualification of new equipment, instrumentation, and controlling software according to standard operating procedures, as appropriate. Coordinates and oversees vendor installation and qualification, as needed.
• Performs preventative maintenance on analytical instruments and/or coordinate necessary maintenance with external vendors.
• Responsible for maintaining life cycle documentation of equipment and instrumentation in accordance with applicable SOPs.
• Performs calibration and/or verification of validated instrumentation according to SOP requirements, inclusive of appropriate documentation.
• Partners cross functionally to troubleshoot equipment and instrumentation and to identify new equipment needs, budgetary requirements, and RFP's.
• Partners with Facilities Management to ensure suitability of equipment and instrument infrastructure.
• Efficiently and correctly repair and/or coordinate repair disabled analytical instruments and laboratory equipment to insure minimal downtime.
• Works collaboratively with external vendors and internal IT to validate instrument software.
• Establishes Preventative Maintenance (PM) programs for new analytical instruments and laboratory equipment while maintaining and updating existing PM programs, inclusive of risk assessment and gap analysis.
• Accountable for ensuring equipment and instrumentation is on-boarded and qualified with applicable standards.
• Plays an active role in the development of business continuity plans, preparation, and support.
• Creates and maintains SOPs for instrumentation/metrology. Partner with junior level staff to review drafted SOPs.
• Maintains an accurate inventory of instruments, consumables, and spare parts. Establishes blanket orders for standard consumable needs.
• Works closely with Supply Chain to ensure inventory records and database are kept up to date.
• Acts as liaison with outside contractors and vendors for equipment repairs or contract maintenance.
• Responsible for monitoring and responding to equipment monitoring systems, such as environmental or generator alerts.
• Coordinates after-hours coverage of all systems to ensure effective emergency response.
• Acts as project manager to support lab initiatives, such as facility changes and new instrumentation evaluations.
• Responsible for contributing to the development and tracking of key functional metrics.
• Serves as a subject matter expert to support the audit and inspection process and responds directly to inquiries.
• Responsible for the resolution of quality incidents and applicable corrective and preventative actions.
• Responsible for training employees on equipment and instrumentation usage.
• May provide support to remote facilities on preventative maintenance and/or repair of analytical instruments via telephone. May be required to visit remote facilities on an occasional basis to provide support.
• Mentors and guides junior level staff.
• Performs work in accordance with applicable regulatory requirements.
• Responsible for identifying and driving opportunities for process improvement, supporting six sigma, quality, and safety initiatives.
QUALIFICATIONS
• Bachelor's Degree Required
• Other equivalent combination of education and experience
• 4 years' experience in laboratory environment.
• Related hands-on experience in calibration and repair of measuring and test equipment, inclusive of experience documenting preventative maintained programs.
• Proficient with Windows, Microsoft Office, Word with an emphasis on Excel required.
• Related hands-on experience in troubleshooting laboratory equipment and resolve process issues.
• Ability to read and interpret engineering documents and equipment schematics.
• Experience in the evaluation and on-boarding of new equipment.
• Ability to analyze, interpret, and convey complex technical information.
• Ability to bring projects and deliverables to completion under established expectations.
• Experience with root cause analysis and quality management systems.
• Excellent oral and written communication skills.
• Ability to articulate and present relevant information to the client within assigned functional area and area of expertise.
• Strong organizational skills, and close attention to detail are essential.
• Capable of handling multiple tasks simultaneously and independently.
• Demonstrated “everyday leadership” skills.
• Ability to maintain a minor degree of independence to complete assigned tasks and projects.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Applicable certifications and licenses as required by local regulations.
Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. https://www.q2labsolutions.com/careers
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe
As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status
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Career Focus: Analyst, Laboratory Technology, Quality
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