4 дня назад
Specialist, Quality Control, Equipment (Biotechnology)
74 000 - 118 400$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Specialist, Quality Control, Equipment (Biotechnology): Supporting the lifecycle, maintenance, qualification, calibration, and documentation of QC laboratory equipment in a GMP-regulated biotechnology site with an accent on equipment reliability, compliance, and data integrity. Focus on troubleshooting instrumentation, coordinating vendors and cross-functional teams, managing quality events and CMMS records, and training QC personnel.
Location: On-site in Norwood, Massachusetts, Monday through Friday. Only U.S. persons are eligible due to U.S. export control requirements.
Salary: $74,000–$118,400 per year, with potential discretionary bonus, incentive compensation, or equity award.
Company
develops mRNA technology and medicines through a biotechnology platform.
What you will do
- Support the full lifecycle of QC laboratory equipment, including installation, qualification, maintenance, calibration, relocation, retirement, and documentation.
- Troubleshoot laboratory instrumentation such as UHPLC systems and support investigations into equipment failures, deviations, alarm events, and out-of-tolerance conditions.
- Coordinate preventive maintenance, calibration, qualification, repairs, vendor support, and equipment movement to minimize downtime.
- Manage equipment records, asset induction requests, work orders, inventory, CMMS data, and quality documentation.
- Support deviations, change controls, CAPAs, investigations, periodic reviews, method implementation, and continuous improvement initiatives.
- Write and maintain SOPs, work instructions, forms, and training materials; train QC personnel on equipment operation and routine maintenance.
Requirements
- Bachelor’s degree in a relevant scientific discipline.
- 3–5 years of experience in a GMP-regulated pharmaceutical, biotechnology, or related laboratory environment.
- Working knowledge of cGMP regulations, Good Documentation Practices, and Data Integrity (ALCOA+) principles.
- Experience with laboratory equipment, instrumentation, or quality systems.
- Strong organizational, communication, and problem-solving skills with the ability to work cross-functionally.
- Must qualify as a U.S. person under U.S. export control requirements; non-U.S. persons cannot be sponsored for an export control license.
Culture & Benefits
- Healthcare coverage and voluntary benefit programs.
- Fitness, mindfulness, and mental health resources.
- Family planning benefits, including fertility, adoption, and surrogacy support.
- Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
- Savings and investment programs, plus location-specific benefits.
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