Sr. Laboratory Specialist

Role Summary

Sr. Laboratory Specialist responsible for testing medical devices and MDCPs, ensuring data integrity, mentoring laboratory staff, troubleshooting equipment, authoring and reviewing technical documents, leading investigations, supporting test method development and transfer, maintaining instrument calibration, and driving improvements in laboratory efficiency, safety, and compliance in a regulated environment.

Responsibilities

• Perform testing (physical, functional, visual, etc.) on medical devices and combination products (MDCPs) using moderately to highly complex laboratory instrumentation with minimal 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 SOPs, work instructions, and related materials.
• Lead laboratory investigations related to deviations, OOS results, and equipment issues; collaborate with Quality and Engineering to ensure timely closure of investigations.
• Support test method development, validation and transfer activities; serve as SME for current laboratory test method capabilities and support method introduction and refinement.
• Ensure instrumentation and equipment are properly maintained and calibrated; support timely resolution of calibration alerts.
• Drive improvements in laboratory efficiency, safety and compliance; identify and implement new technologies, techniques and best practices.

Qualifications

• Required: Bachelor's degree with at least 2 years of experience; OR a Master's degree with 0+ years; 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: 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 Requirements: Able to function in a lab and office setting; may work with actual product and packaging systems and may operate pallet-moving equipment; may work in rooms of varied temperature and humidity; may stand for extended periods; lifting within safe limits; capable of using electronic systems to coordinate testing documentation and record test results.
• Travel/Environment: Use of PPE (safety goggles, lab coats, gloves) may be required; travel for test method support, job-related training, equipment evaluation, and development should be expected.