Scientist III, Quality Control (Middletown, VA)
About The Position
Within Thermo Fisher Scientific’s Clinical Diagnostics Division, the Scientist III position supports regulated diagnostic product operations, manufacturing excellence initiatives, and Quality Control operations at the Middletown, VA site. This role is responsible for providing technical leadership in support of stability programs, investigations, assay performance monitoring, process improvements, and diagnostic product lifecycle activities. The Scientist III will collaborate cross-functionally with Manufacturing, Quality Assurance, Regulatory Affairs, R&D, and Operations teams to support technology transfer, process validation, troubleshooting activities, and continuous improvement initiatives. This individual will lead complex investigations, evaluate technical data, support CAPA implementation, and ensure compliance with cGMP, ISO 13485, and internal quality system requirements. This role has a direct impact on patient care and diagnostic product quality by ensuring reliable and compliant manufacturing and QC processes that support the delivery of high-quality clinical diagnostic products to customers worldwide.
Requirements
- Master’s degree with 3+ years or Bachelor’s degree with 5+ years of experience in GMP-regulated pharmaceutical, biotechnology, diagnostics, or medical device manufacturing environments preferred.
- Hands-on experience with High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) required.
- Knowledge of stability programs, product lifecycle management, and QC laboratory operations.
- Experience with process validation, qualification activities, and change control systems.
- Expert knowledge of cGMP regulations, ISO 13485 standards, and quality systems.
- Strong analytical, statistical analysis, and technical writing skills.
- Excellent verbal and written communication skills with the ability to work collaboratively in a matrix environment.
- Ability to participate in technical discussions with external stakeholders and customers as needed.
- Ability to support manufacturing operations and critical investigations, including occasional weekend or after-hours support.
Nice To Haves
- Preferred fields of study include Chemical Engineering, Chemistry, Biochemistry, Biotechnology, Microbiology, or related scientific disciplines.
- Experience leading root cause investigations, OOS investigations, deviations, CAPAs, and corrective actions preferred.
- Experience supporting internal/external audits and regulatory inspections preferred.
- Experience troubleshooting complex analytical or diagnostic instrumentation platforms preferred.
- Experience mentoring colleagues and providing technical training is preferred.
Responsibilities
- Provide technical support for QC laboratory operations and manufacturing processes.
- Perform routine and non-routine analytical testing using HPLC, GC, and other laboratory instrumentation.
- Support raw material, in-process, finished product, and stability testing activities.
- Lead investigations related to deviations, OOS results, nonconformances, and product quality events.
- Support stability testing programs and trend analytical data to identify process or product issues.
- Support process validation, assay qualification, and technology transfer activities.
- Review technical documentation including protocols, reports, SOPs, and change controls.
- Support audit readiness activities and participate in regulatory inspections as required.
- Drive continuous improvement initiatives focused on compliance, efficiency, and product quality.
- Mentor junior scientists and provide technical expertise across the organization.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
