Description
We are seeking a Technical Laboratory Specialist to perform a variety of technical procedures and experimental execution in support of sample analysis and validation. As a key member of our team, you will be responsible for root cause analysis, troubleshooting, and supporting process improvements.
Key Responsibilities:
- Perform and document analytical procedures in accordance with company procedures and regulatory guidelines
- Assist in troubleshooting and process improvements to increase data quality, lower costs, or reduce turnaround times
- Act as a technical resource for laboratory staff and support the team in the absence of the line manager
- Perform routine data analysis to determine if an analytical procedure is proceeding according to expectations and that the results are within acceptable tolerances
- Identify and document potential performance errors or unusual results and escalate to senior lab personnel
- Prepare data analysis results for upload to LIMS system under the guidance of senior level staff
- Contribute to CAPA investigations, deviations, and resolution
- Maintain clear, accurate, and timely communications with cross-functional stakeholders
- Assist in maintaining laboratory equipment and may offer suggestions for new equipment
- Assist in good housekeeping of the lab environment, consistent with 6S standards
- Assist in maintaining adequate inventory
- Prepare buffers and solutions for analysis as required
- Perform and document calibration and maintenance of laboratory equipment as assigned
- Perform and document hands-on training for other lab personnel in areas of proven competency as assigned
- Participate in continuing education through self-study, attending training sessions and lectures, and meetings
- Lead laboratory or cross-functional projects and assist with implementation of changes
- Contribute to the design and development execution of routine methods/assays under moderate supervision
- Support safety, quality, and 6S requirements and initiatives
- Comply with company procedures and applicable regulatory requirements
Requirements:
- Associate's Degree or Bachelor's Degree in Biology or Chemistry
- 1 year of experience in a regulated laboratory environment
- Sound knowledge of principles, theories, and concepts in job area
- Working knowledge of applicable regulatory standards within area of responsibility
- Proficiency with relevant laboratory techniques
- Knowledge of laboratory safety and infection control procedures and practices
- Strong technical knowledge of complex testing procedures and science supporting the analysis
- Proficiency with complex laboratory calculations regarding batches and specimens
- Ability to troubleshoot laboratory equipment and resolve process issues
- Good computer skills, including proficiency with Microsoft Excel, PowerPoint, and Word
- Effective organizational and interpersonal skills
- Effective communication and presentation skills
- Capable of handling multiple tasks simultaneously
- Strong attention to detail and accuracy
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients