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16 часов назад

QC Manager

Тип работы
fulltime
Грейд
senior
Английский
c1
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 Manager (Microbiology and Chemistry Laboratories): Leading laboratory operations and quality control testing for raw materials, in-process materials, finished products, stability programs, and method transfers with an accent on FDA, USP, cGMP, and quality-system compliance. Focus on laboratory validation, root cause investigations, change control, analyst development, and continuous improvement through automation and testing-method enhancements.

Location: Jayuya, Puerto Rico

Company

hirify.global develops healthcare products and solutions guided by a mission to save and sustain lives.

What you will do

  • Lead and manage Microbiology and Chemistry Laboratory operations, coordinating activities with Manufacturing and Supply Chain.
  • Supervise, train, and develop laboratory personnel while ensuring efficient, cost-effective, and compliant service delivery.
  • Establish and maintain laboratory policies, procedures, specifications, testing programs, and quality monitoring processes.
  • Manage laboratory investigations, root cause analysis, trend analysis, stability programs, and change controls.
  • Oversee laboratory validation, method transfers, validation sample testing, and participation in process validation and revalidation.
  • Manage laboratory budgets, capital expenditures, equipment, software, service contracts, and maintenance suppliers.

Requirements

  • Bachelor’s degree in Chemistry, Microbiology, or a related scientific discipline.
  • At least 8 years of Quality Systems experience in a regulated environment and at least 3 years of laboratory management or supervisory experience.
  • Experience with wet chemistry and/or microbiology laboratory procedures, laboratory validation, method transfers, and stability programs.
  • Strong knowledge of FDA regulations, USP standards, cGMPs, laboratory operations, and quality systems.
  • Practical Root Cause Analysis experience, applied statistics, change management, employee development, presentation, facilitation, and conflict-resolution skills.
  • Full professional proficiency in English and Spanish is required.

Culture & Benefits

  • Work in a culture focused on courage, trust, collaboration, accountability, and performance excellence.
  • Collaborate with Manufacturing, Supply Chain, Quality, Regulatory, and R&D functions.
  • Access to employee development, educational assistance, paid time off, paid holidays, and family and medical leave benefits where applicable.
  • Eligible US roles may include medical and dental coverage, insurance, retirement savings, employee stock purchase, and other benefits; the stated US benefits exclude Puerto Rico.

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