5 часов назад
Senior Analyst, QC Microbiology
75 000 - 116 250$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Analyst, QC Microbiology (GMP/biomanufacturing): Performing and documenting microbiological testing for raw materials, in-process and finished products, and environmental samples with an accent on GMP compliance, data review, and laboratory process control. Focus on leading investigations, authoring quality records and SOPs, implementing compendial changes, and serving as a microbiology subject matter expert during regulatory inspections.
Location: USA - OH - West Chester. Day shift: Sunday through Wednesday, 10-hour shifts. Off-shift support may be required.
Salary: $75,000–$116,250 per year, plus an annual cash bonus program.
Company
is a technology-focused biomanufacturing company building a sustainable network of end-to-end manufacturing solutions for medicines.
What you will do
- Perform and document microbiological testing of raw materials, in-process and finished products, and environmental samples.
- Review laboratory data and documentation to ensure GMP compliance, identify trends, and author related reports.
- Lead or participate in investigations, deviations, CAPAs, change controls, and corrective or preventive actions affecting QC processes and results.
- Author SOPs, review work instructions and logbooks, and approve qualification and quality records as a subject matter expert.
- Maintain and troubleshoot laboratory equipment, methods, and processes; coordinate qualification activities and manage logistics in MAXIMO or CMMS.
- Train QC employees, mentor colleagues, coordinate laboratory activities, and represent the function during regulatory inspections.
Requirements
- Prior experience in a regulated GMP environment.
- Working knowledge of cGXP requirements and strong familiarity with production operations.
- Excellent attention to detail and problem-solving skills.
- Bachelor’s degree in microbiology, science, or a closely related subject.
- Five years of QC microbiology laboratory experience and experience supporting microbiological testing in a sterile pharmaceutical operation are preferred.
- Work authorization or visa sponsorship is not available for this position.
Culture & Benefits
- Work within a quality management system governed by GMP, SOPs, quality policies, and applicable regulations.
- Benefits include a 401(k) plan with company match, medical, dental and vision coverage, and life and disability insurance.
- Paid vacation, paid holidays, other paid leave, family-building benefits, and caregiving support.
- Tuition reimbursement and a total rewards program.
- The role involves standing, walking, repetitive motion, chemical use, gowning, sterile garments, and PPE as required.
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