Sr. Laboratory Specialist

Role Summary

As a Sr. Laboratory Specialist, you will perform testing on medical devices and combination products using complex laboratory instrumentation, ensure data integrity and regulatory compliance, and mentor laboratory technicians. You will lead investigations, contribute to test method development and transfer activities, and drive improvements in laboratory efficiency, safety, and compliance.

Responsibilities

• Perform testing (physical, functional, visual, etc.) on medical devices and combination products (MDCPs) using moderate to highly complex laboratory instrumentation with minimum supervision.
• Maintain data integrity and ensure compliance with company SOPs, GLP and cGMP regulations.
• Train, guide and mentor laboratory technicians, fostering skill development and compliance with best practices.
• Provide technical expertise to troubleshoot and resolve equipment and testing issues, ensuring operational readiness.
• Author and review technical documents, including standard operating procedures (SOPs), work instructions, etc.
• Lead laboratory investigations related to deviations, out-of-specification (OOS) results and equipment issues. Collaborate with Quality and Engineering teams to ensure timely closure of investigations.
• Support test method development, validation and transfer activities. Serve as SME for current laboratory test method capabilities, support test method introduction, and refinement activities.
• Ensure that instrumentation/equipment are properly maintained and calibrated. Support timely resolution of calibration alerts.
• Drive improvements in laboratory efficiency, safety and compliance. Support the identification and implementation of new technologies, techniques and best practices.

Qualifications

• Required: Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience
• Required: Experience operating and maintaining device and/or packaging equipment.
• Required: Knowledge of electronic Laboratory Notebooks (eLNs).
• Required: Experience working within a regulated environment.
• Required: Good communication (oral and written) and interpersonal skills.
• Required: Critical thinking/problem solving skills.
• Required: An ability to work independently as well as a member of a team in a fast-paced environment.
• Required: Working knowledge of Excel, Word, etc.
• Preferred: Relevant pharmaceutical experience
• Preferred: Understanding of regional pharmaceutical compendia testing requirements
• Preferred: Excellent communication and interpersonal skills
• Preferred: Strong organizational skills and attention to detail
• Preferred: Demonstrated leadership capabilities and mentoring skills

Additional Requirements

• Physical/Mental: The role operates in a lab and office setting and may require working with actual products and packaging systems. Standing for extended periods, occasional lifting within safety limits, and use of electronic systems to coordinate testing documentation and record results.
• Travel/Environment: Travel for test method support, job-related training, equipment evaluation and development should be expected.