4 дня назад
Specialist, Quality Control (AI)
74 000 - 118 400$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Specialist, Quality Control (AI) (LIMS, Chromeleon, GMP): Supporting QC laboratory systems and AI-powered digital solutions for biopharmaceutical quality control with an accent on system administration, validation, data integrity, and regulatory compliance. Focus on troubleshooting laboratory applications, deploying digital enhancements, and integrating AI-enabled workflows into GMP-controlled QC operations.
Location: Cambridge, Massachusetts / Norwood, Massachusetts, United States. The role requires individuals who qualify as U.S. persons under U.S. export control laws.
Salary: $74,000–$118,400 per year, with potential discretionary bonus, incentive compensation, or equity.
Company
develops mRNA technology and biopharmaceutical solutions to transform how medicines are created and delivered.
What you will do
- Support QC laboratory systems, including LIMS, Chromeleon, and other enterprise laboratory applications.
- Manage user access, configurations, software maintenance, installations, upgrades, and Tier 1 troubleshooting.
- Support testing, validation, deployment, and continuous improvement of laboratory system enhancements.
- Maintain SOPs, work instructions, training materials, lifecycle documentation, deviations, change controls, CAPAs, and periodic reviews.
- Support AI-powered and digital solutions for QC data review, trending, reporting, workflow automation, and laboratory operations.
- Train QC personnel and collaborate with QC, Digital, Automation, IT, and Regulatory stakeholders.
Requirements
- BS degree in science or a relevant scientific field.
- 3–5 years of experience in the biotechnology or biopharmaceutical industry, preferably in QC, Digital, or Automation.
- Experience with biopharmaceutical operations and GMP requirements.
- Understanding of laboratory informatics systems such as LIMS or chromatography data systems.
- Strong problem-solving, troubleshooting, communication, and cross-functional collaboration skills.
- Must qualify as a U.S. person under U.S. export control laws; non-U.S. persons are not eligible for this position.
Nice to have
- Familiarity with AI applications, data analysis tools, and digital solutions in a GMP environment.
- Experience troubleshooting AI-related QC processes.
Culture & Benefits
- Competitive healthcare and voluntary benefit programs.
- Fitness, mindfulness, and mental health support.
- Family planning benefits, including fertility, adoption, and surrogacy support.
- Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
- Savings and investment programs, plus location-specific benefits.
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