Associate III, Quality Control

Job Description

The Associate III is responsible for supporting, leading/participating in team initiatives regarding compliance, documentation, investigations, deviations, OOS/AR, systematic IA’s, environmental excursions, periodic reviews, Annual Product Reviews and retest protocols. Drive CAPA, periodic review & change control activities. Mentor others in aspects of quality impact assessment (including QA & regulatory notification) quality systems, and risk assessment. Provides support and presents for internal & external regulatory inspections, as applicable. Keen understanding of the laboratory operations/testing process, equipment/instrumentation, and analytical test methods. Able to apply scientific understanding of validation & data analysis for reporting results.

• Author technically-sound simple to moderately complex reports with limited guidance.
• Routinely contribute to and support complex problem solving and manage noncomplex problem solving.
• Proactively identify, communicate and monitor business changes that could impact quality or compliance within the department & across departments.

You are a leader and are passionate about solving technical, compliance gaps and areas for improvement or remediation related to quality or process. You are confident in making decisions that have potential compliance impact to methods, results, product, and/or Quality systems.

Qualifications

• B.S. with 4+ years experience or M.S. with 2+ years experience in comparable role with GMP, compliance experience.
• Excellent technical writing skills, strong presentation, oral and written communication skills.
• Strong organizational skills and ability to multi-task / coordinate multiple activities in parallel.
• Demonstrated problem solving skills with a keen understanding of the laboratory operations/testing process, equipment/instrumentation, and analytical test methods.
• Able to work effectively, independently and within a team framework across business and multiple levels.

• Proficient in Trackwise, LabWare LIMs.

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects usasa team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.