39 минут назад
Quality Control Chemist
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Control Chemist (Analytical Chemistry): Reviewing and approving analytical chemistry documentation, laboratory data, methods, validation records, and quality investigations with an accent on cGMP, cGLP, ISO 17025, A2LA, and USP compliance. Focus on ensuring data integrity, conducting audits, evaluating root causes and CAPA plans, and maintaining controlled quality systems for HPLC, HPLC-MS/MS, GC-MS, and UV-Vis testing.
Location: Houston, Texas, United States
Company
provides regulated laboratory testing services for sterility, bacterial endotoxins, microbial detection, beyond-use dating, and active ingredient potency.
What you will do
- Review, approve, and maintain analytical chemistry documentation, laboratory data, test reports, validation records, and quality records.
- Apply cGMP, cGLP, ISO 17025, A2LA, USP, SOP, and Quality Management System requirements.
- Review analytical methods and documentation for UV-Vis spectrophotometry, HPLC, HPLC-MS/MS, GC-MS, and related instrumentation.
- Review quality investigations involving OOS results, NCRs, deviations, CAPA, change controls, and customer complaints.
- Support regulatory inspections, client audits, accreditation assessments, internal audits, and routine laboratory compliance walkthroughs.
- Maintain controlled quality documents, training materials, audit findings, quarantined-material records, and continuous improvement initiatives.
Requirements
- Bachelor’s degree in Chemistry, Analytical Chemistry, Biochemistry, or a related scientific discipline.
- Strong understanding of analytical chemistry techniques and instrumentation, including HPLC, HPLC-MS/MS, GC-MS, and UV-Vis.
- Working knowledge of method validation, data review, laboratory quality systems, and GMP/GLP documentation.
- Strong attention to detail and commitment to data integrity, accuracy, completeness, and traceability.
- Excellent written and verbal communication skills, with the ability to work independently and collaborate across functions.
- Proficiency with Microsoft Office and electronic document management systems.
Nice to have
- Experience in an ISO 17025, cGMP, or cGLP-regulated laboratory environment.
- Experience supporting analytical chemistry testing laboratories.
- ASQ certification or HPLC certification.
Culture & Benefits
- Collaborate with laboratory operations and cross-functional teams on quality and regulatory objectives.
- Contribute to continuous improvement of quality systems, documentation, and laboratory compliance.
- Work in a detail-oriented environment focused on data integrity and reliable testing outcomes.
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