обновлено 2 дня назад
Quality Control Analyst II (Biotech)
70 200 - 81 900$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Control Analyst II (Biotech): Performing routine and moderately complex laboratory testing for GMP manufacturing and stability programs with an accent on data analysis, investigations, documentation, and regulatory compliance. Focus on executing stability protocols, troubleshooting deviations and OOS results, maintaining GMP records, and supporting method validation and continuous improvement.
Location: Walkersville, Maryland, United States; office-based, Monday–Friday, 8:00 AM–5:00 PM EST
Salary: $70,200–$81,900 base annual salary
Company
operates globally connected sites that manufacture medicines and support life sciences customers in turning breakthrough ideas into viable therapies.
What you will do
- Perform routine and moderately complex testing of in-process, release, environmental, and stability samples with minimal supervision.
- Review, analyze, interpret, and report laboratory data accurately and on time.
- Execute GMP stability protocols, coordinate testing, manage sample inventories, and review documentation.
- Investigate deviations, out-of-specification results, and atypical results, including root-cause analysis and corrective actions.
- Author and maintain SOPs, test methods, protocols, reports, and other GMP documentation.
- Support training, method transfers, validation, equipment qualification, sample management, inventory control, and continuous improvement activities.
Requirements
- At least 3 years of experience in a pharmaceutical, biotechnology, life sciences, or other regulated laboratory environment.
- Associate degree, technical certification, military laboratory training, or equivalent laboratory experience preferred; relevant GMP experience may substitute for formal education.
- Working knowledge of analytical laboratory techniques, aseptic practices, GMP operations, data integrity, quality systems, and laboratory compliance.
- Experience with laboratory investigations, deviations, OOS results, CAPAs, or other quality events.
- Strong analytical, organizational, troubleshooting, documentation, communication, and collaboration skills.
Nice to have
- Experience supporting GMP stability programs, including sample management, testing coordination, inventory tracking, and documentation.
Culture & Benefits
- Performance-related bonus.
- Medical, dental, and vision insurance.
- 401(k) matching plan.
- Life insurance and short- and long-term disability insurance.
- Employee assistance programs and paid time off.
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