2 дня назад
Quality Control Microbiologist
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Control Microbiologist (Microbiology/Quality Systems): Reviewing sterile and non-sterile microbiological testing data, documentation, and investigations to maintain compliance with cGMP, cGLP, ISO 17025, A2LA, and USP requirements. Focus on evaluating OOS, NCR, deviations, CAPA, audits, root-cause analyses, and data integrity across regulated laboratory operations.
Location: Houston, Texas, United States
Company
Scientific testing and solutions provider operating an FDA-registered cGMP testing and calibration laboratory serving pharmaceutical, medical, compounding, hospital, and clinical research clients.
What you will do
- Review sterile and non-sterile microbiology test data, worksheets, logbooks, reports, and quality records.
- Apply cGMP, cGLP, ISO 17025, A2LA, USP, SOP, and quality management system requirements.
- Review and approve OOS investigations, NCRs, deviations, CAPAs, change controls, and customer complaints.
- Evaluate root-cause analyses and corrective action plans for laboratory and process issues.
- Support and conduct internal audits, regulatory inspections, client audits, accreditation assessments, and compliance walkthroughs.
- Write, review, and approve SOPs, work instructions, forms, quality manuals, training materials, and controlled documentation.
Requirements
- Bachelor’s degree in Microbiology, Biology, or a related life science.
- Knowledge of cleanroom practices and microbiological testing principles.
- Strong attention to detail and commitment to data integrity and regulatory compliance.
- Excellent written and verbal communication skills.
- Ability to work independently and collaborate with cross-functional teams.
- Proficiency with Microsoft Office applications and electronic document management systems.
Nice to have
- Experience with sterile or non-sterile microbiology testing.
- Experience in an ISO 17025, cGMP, or cGLP-regulated laboratory.
- Experience reviewing GMP/GLP documentation and quality investigations.
- ASQ certification or related quality credentials.
Culture & Benefits
- Full-time position supporting quality control and regulatory objectives.
- Work alongside laboratory operations, quality leadership, and cross-functional teams.
- Contribute to continuous improvement in quality systems, documentation, and laboratory compliance.
- Mission focused on patient safety and science-based solutions.
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