4 часа назад
Analyst II, QC Microbiology
60 000 - 86 250$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Analyst II, QC Microbiology (Pharmaceutical Quality Control): Performing microbiological quality testing and documenting results for pharmaceutical raw materials, in-process and finished products, utilities, and environmental samples with an accent on cGMP compliance, investigations, and quality documentation. Focus on identifying data trends and root causes, coordinating qualification and process improvement activities, and supporting audits and inspections.
Location: West Chester, Ohio, United States
Salary: $60,000–$86,250 per year
Company
Technology-focused biomanufacturing company developing sustainable, end-to-end manufacturing solutions for pharmaceutical products.
What you will do
- Conduct and document microbiological testing of raw materials, in-process and finished products, stability samples, water, gas, utilities, and environmental samples.
- Write, review, and revise SOPs, work instructions, and other documentation for cGMP manufacturing.
- Participate in investigations involving QC processes, sampling, deviations, data, and testing.
- Identify data trends, root causes, temporary and permanent corrective actions, and compliance improvements.
- Author and review quality records, including Deviations, CAPAs, and Change Controls.
- Coordinate qualification activities, support audits and inspections, review logbooks, and contribute to process improvement initiatives.
Requirements
- Working knowledge of cGXP requirements and strong familiarity with production operations.
- Good problem-solving skills.
- Bachelor’s degree in biology, microbiology, or a related discipline preferred.
- At least two years of laboratory experience in the pharmaceutical industry preferred.
- Prior experience with microbiological testing in a sterile pharmaceutical operations environment preferred.
- Sponsorship or support for work authorization, including visas, is not available.
Culture & Benefits
- Full-time position with an annual cash bonus program.
- 401(k) plan with company match.
- Medical, dental, and vision healthcare coverage.
- Paid vacation, paid holidays, and other paid leave.
- Tuition reimbursement, family-building benefits, life and disability insurance, and caregiving support.
- Work includes standing, walking, repetitive motion, chemical usage, and required gowning, sterile garments, and PPE.
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