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3 часа назад

QC Specialist, Lab Services I (Biotechnology)

63 298 - 83 077$
Формат работы
onsite
Тип работы
fulltime
Грейд
junior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
QC Specialist, Lab Services I (Biotechnology): Managing QC samples, retain samples, documentation, and shipments in a biopharmaceutical laboratory with an accent on cGMP compliance, electronic sample management, and quality systems. Focus on reconciling physical samples with LIMS records, investigating non-conformances, handling CAPA records, and supporting regulatory audits.

Location: Onsite in Raritan, New Jersey, United States. The role requires accommodating evening and weekend shifts, may require up to 5% travel, and occasionally involves lifting up to 20 pounds.

Salary: $63,298–$83,077 USD base pay per year, plus performance-based bonus and/or equity where eligible.

Company

hirify.global is a global biotechnology company developing cell therapies, including CAR-T, TCR-T, and natural killer cell-based therapies.

What you will do

  • Manage QC samples and retain samples, including periodic inspection and consolidation.
  • Prepare and independently review QC documentation, logbooks, and LIMS records.
  • Coordinate internal and external sample shipments and maintain related documentation.
  • Reconcile physical sample quantities in freezers and refrigerators with electronic records.
  • Document and perform sample-management non-conformance investigations.
  • 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.
  • Understanding of cGMP and regulatory requirements, policies, and guidelines for QC laboratories.
  • Experience with QC document reviews, regulatory inspection processes, quality systems, and retain-sample management using eLIMS.
  • Proficiency with Microsoft Office applications and laboratory management software.
  • Authorization to work in the United States is required; employment eligibility will be verified through Form I-9 and E-Verify.

Culture & Benefits

  • Permanent full-time employees receive medical, dental, and vision insurance.
  • 401(k) retirement plan with a company match that fully vests on day one.
  • Eight weeks of paid parental leave after three months of employment.
  • Paid vacation, personal, sick, floating holiday, and company holiday time.
  • Additional benefits include flexible spending and health savings accounts, disability coverage, legal assistance, commuter benefits, family-care resources, and well-being programs.

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