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1 день назад

Sr. QA Specialist - Pharmaceutical Manufacturing

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US/Denmark
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
Sr. QA Specialist - Pharmaceutical Manufacturing (GMP/Quality Assurance): Reviewing and approving manufacturing documentation and batch records to certify compliance for biologics produced at a commercial-scale GMP facility, with an accent on deviations, validation documentation, CAPA, and QA training. Focus on mentoring QA colleagues, resolving quality issues with Manufacturing and Quality Control, and driving cross-functional quality improvement projects.

Location: Onsite at the West Lebanon, New Hampshire bio-production facility, Monday–Friday.

Company

hirify.global is a global healthcare company developing and manufacturing treatments for diabetes, obesity, rare blood and endocrine disorders, and other serious chronic diseases.

What you will do

  • Review and approve manufacturing, support, batch, testing, and ancillary records for compliance with internal standards and GMP.
  • Exercise QA signature authority for individual batch records and related documentation.
  • Review and assess deviations, including tracking, follow-up, reporting, and trend analysis.
  • Review and approve validation documentation and corrective and preventive action reports.
  • Train, mentor, and develop QA colleagues, including delivering compliance and QA-related training.
  • Partner with Manufacturing and Quality Control to resolve record review, audit, and deviation issues and support cross-functional quality projects.

Requirements

  • Bachelor’s degree in a scientific or life science discipline.
  • At least 10 years of experience with a bachelor’s degree, or 8 years with a master’s degree.
  • Six years of direct QA experience preferred.
  • Extensive knowledge and proven experience in GMP API manufacturing within the pharmaceutical industry.
  • Excellent written and verbal English communication skills are required.
  • Strong planning, organization, judgment, stakeholder management, collaboration, and QA mentoring skills.

Nice to have

  • Master’s degree in a scientific or life science discipline.

Culture & Benefits

  • Work in a supportive manufacturing community focused on ethics, quality, and patients.
  • Access to career development opportunities, resources, and mentorship.
  • Work at a 24/7 commercial-scale GMP manufacturing facility producing biologics and other medicines.
  • Local and international travel of approximately 0–5%.
  • Inclusive recruitment process and equal employment opportunity.

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