3 дня назад
Analyst, QC Micro – Lab (Microbiology)
24 - 35$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Analyst, QC Micro – Lab (Microbiology) (cGMP microbiological testing): Performing microbiological testing and quality control activities supporting a site microbiological control program with an accent on routine sampling, utility testing, documentation, and regulatory compliance. Focus on analyzing laboratory data, identifying trends and deviations, supporting CAPA and process improvements, and maintaining cGMP systems.
Location: USA - OH - West Chester; Monday–Friday schedule with 24/7 on-call support as needed
Base pay: $24.00–$34.50 per hour
Company
is a technology-focused biomanufacturing company developing sustainable, end-to-end manufacturing solutions for medicines.
What you will do
- Perform routine microbiological sampling, utility testing, in-process testing, autoclaving, and parts washing in accordance with cGMP.
- Conduct visual inspections, verify materials, and monitor laboratory equipment and systems for performance issues.
- Maintain laboratory notebooks, logbooks, quality records, sample receipts, and archived documentation.
- Write, review, and revise SOPs and work instructions for manufacturing, equipment, systems, and facilities.
- Analyze data trends, identify root causes, report quality metrics, and recommend corrective actions.
- Support audits, inspections, CAPA, compliance, process improvement, training, and cross-functional SME activities.
Requirements
- Experience performing microbiological testing or analytical laboratory work in a regulated or cGMP environment.
- Ability to independently apply laboratory and microbiological skills within the role.
- Ability to analyze laboratory data, identify trends or deviations, and escalate recommendations.
- Working knowledge of cGMP documentation requirements, including logbooks, deviations, and SOP compliance.
- Ability to prepare clear and accurate technical documentation.
- Ability to work onsite in West Chester, Ohio, and provide 24/7 on-call support as needed; work authorization or visa sponsorship is not available.
Nice to have
- Bachelor’s degree in biology, microbiology, or a related discipline.
- At least one year of experience in a regulated or cGMP laboratory environment.
- Experience with laboratory instrumentation, cGXP requirements, production operations, Microsoft Office, cGMPs, and FDA regulations.
Culture & Benefits
- Annual cash bonus program and 401(k) plan with company match.
- Medical, dental, and vision coverage, life and disability insurance, and family-building benefits.
- Paid vacation, paid holidays, and other paid leaves of absence.
- Tuition reimbursement and caregiving support.
- Work governed by the Quality Management System, quality policies, SOPs, cGMP, and applicable regulations.
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