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.
Responsibilities:
- Perform and document analytical procedures in accordance with company procedures and regulatory guidelines.
- Troubleshoot and implement 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.
- Analyze data 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.
- Communicate clearly, accurately, and in a timely manner with cross-functional stakeholders.
- Assist in maintaining laboratory equipment and may offer suggestions for new equipment.
- Maintain 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.
Qualifications:
- Bachelor's Degree or equivalent combination of education and experience.
- Typically requires >2 years of experience.
- Minimum 1 year of experience in a regulated laboratory environment preferred.
- 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.