3 дня назад
Specialist, Quality Control, Equipment (Biotech)
74 000 - 118 400$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Specialist, Quality Control, Equipment (Biotech): Managing the lifecycle, maintenance, qualification, calibration, and documentation of QC laboratory equipment in a GMP-regulated biopharmaceutical environment with an accent on equipment reliability, compliance, and data integrity. Focus on troubleshooting instrumentation, coordinating vendors and cross-functional teams, supporting quality investigations, and maintaining equipment systems and documentation.
Location: On-site Monday–Friday at the Norwood, Massachusetts site, United States. Only U.S. persons are eligible due to U.S. export control requirements.
Salary: $74,000–$118,400 annually, plus potential discretionary bonus, incentive compensation, or equity award.
Company
develops an mRNA technology platform and medicines intended to transform how treatments are created and delivered.
What you will do
- Manage the 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, deficiencies, and laboratory operations.
- Coordinate preventive maintenance, calibration, qualification, repairs, alarm responses, and vendor support to minimize equipment downtime.
- Act as the primary QC contact for equipment-related issues and collaborate with Facilities, Metrology, Engineering, Digital teams, and external vendors.
- Maintain equipment inventories, CMMS records, work orders, quality documentation, SOPs, work instructions, forms, and training materials.
- Train QC personnel, support quality systems activities, perform data trending and reporting, and contribute to method implementation and continuous improvement.
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 principles, including ALCOA+.
- Experience with laboratory equipment, instrumentation, or quality systems.
- Strong organizational, communication, troubleshooting, and problem-solving skills in cross-functional settings.
- Must qualify as a U.S. person under U.S. export control laws; 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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