3 часа назад
Analytical Data Review Scientist (Biotechnology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Analytical Data Review Scientist (Biotechnology): Analyzing, tracking, and reporting laboratory and business data while supporting pharmaceutical analytical testing with an accent on data analytics, relational databases, laboratory documentation, and quality compliance. Focus on reviewing electronic analytical data, troubleshooting HPLC, UPLC, GC, and UV/Vis workflows, investigating OOS/OOT results, and supporting method validation and transfer.
Location: Onsite in Houston, Texas, United States
Company
is an FDA-registered CGMP testing and calibration laboratory providing scientific solutions for pharmaceutical, compounding, healthcare, and clinical research organizations.
What you will do
- Analyze, track, and report laboratory and business data supporting operations, quality, and compliance.
- Support timely and accurate pharmaceutical analytical sample testing, data management, and documentation.
- Operate, troubleshoot, and maintain HPLC, UPLC, GC, and UV/Vis spectrophotometers.
- Perform electronic data review using LIMS platforms such as Empower and EagleTrax.
- Conduct technical reviews of analytical data and support OOS/OOT investigations.
- Contribute to method development, validation, transfer, regulatory submissions, and quality systems.
Requirements
- Bachelor’s or master’s degree in Chemistry, Analytical Chemistry, Biochemistry, Pharmacy, or a related scientific field.
- At least 2 years of experience in a regulated pharmaceutical analytical laboratory, or an equivalent combination of education and experience.
- Proficiency with analytical instruments including HPLC, UPLC, GC, and UV/Vis spectrophotometers.
- Experience with LIMS and electronic data review, laboratory documentation, and analytical data assessment.
- Knowledge of cGMP, cGLP, ISO 17025, USP, A2LA, and data integrity principles.
- Strong attention to detail, organization, communication, and independent collaboration skills; proficiency in Microsoft Office.
Nice to have
- Experience across multiple laboratory workstations and cross-functional operations.
- Technical consultation experience and knowledge of emerging analytical technologies.
- Certification in HPLC.
Culture & Benefits
- Work in a state-of-the-art FDA-registered CGMP testing and calibration laboratory.
- Support patient safety through fact-based, science-based testing and compliance solutions.
- Collaborate with clients across pharmaceutical, healthcare, and research organizations.
- Contribute to scientific approaches addressing healthcare and regulatory challenges.
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