3 дня назад
QC Specialist, Lab Services I (Biotechnology)
63 298 - 83 077$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QC Specialist, Lab Services I (Biotechnology) (Quality Control/Lab Services): Managing QC samples, retains, documentation, shipments, and laboratory records in a biopharmaceutical environment with an accent on cGMP compliance, LIMS, and regulatory quality systems. Focus on reconciling physical samples with electronic records, investigating non-conformances, handling corrective and preventive actions, and supporting audits.
Location: Raritan, New Jersey, United States; onsite. The role may require up to 5% travel, weekend and evening shifts, and lifting up to 20 pounds.
Salary: $63,298–$83,077 USD per year, plus performance-based bonus and/or equity where eligible.
Company
is a global biotechnology company developing cell therapy platforms, including CAR-T, CAR-NK, CAR-γδ T, and other therapies for serious diseases.
What you will do
- Manage QC samples and retain samples, including periodic inspection and consolidation.
- Prepare and independently review QC documentation, logbooks, and laboratory records.
- Coordinate internal and external sample shipments and maintain related documentation.
- Reconcile physical sample quantities in freezers and refrigerators with LIMS records.
- Document and perform investigations related to sample-management non-conformances.
- Handle corrective and preventive action records and support internal and regulatory audits.
Requirements
- Bachelor’s degree or higher in Biology, Biochemistry, Microbiology, Chemistry, or a related field.
- At least two years of related experience in the medical device, biopharmaceutical, or pharmaceutical industry.
- Knowledge of cGMP requirements, regulatory guidelines, quality systems, and QC document review.
- Experience managing retain samples using electronic systems such as eLIMS or LIMS.
- Proficiency with Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
- Applicants must be authorized to work in the United States.
Culture & Benefits
- Medical, dental, and vision insurance.
- 401(k) retirement plan with a company match fully vested on day one.
- Eight weeks of paid parental leave after three months of employment.
- Paid vacation, personal time, sick time, floating holidays, and eleven company holidays.
- Additional flexible spending, health savings, disability, life insurance, commuter, family-care, and well-being benefits.
- Benefits are available exclusively to permanent full-time employees.
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