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4 дня назад

Manufacturing Compliance Specialist I/II (Swing Shift)

70 000 - 90 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

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TL;DR
Manufacturing Compliance Specialist I/II (Swing Shift) (Biopharmaceutical Manufacturing): Supporting compliant manufacturing operations on the floor through batch documentation review, ERP troubleshooting, material management, and cleanroom readiness with an accent on GMP quality systems and real-time operational guidance. Focus on maintaining manufacturing compliance, coordinating mitigation efforts with Manufacturing and QA, and mentoring floor staff during a Monday–Friday 2:00 PM–10:30 PM shift.

Location: Boulder, Colorado, United States; onsite work on the Manufacturing floor in a clean room environment. Schedule: Monday–Friday, 2:00 PM–10:30 PM.

Salary: $70,000–$90,000 per year.

Company

hirify.global operates in biopharmaceutical manufacturing and develops and supports production processes for biologic products.

What you will do

  • Provide real-time compliance guidance, training, and corrective support during manufacturing operations.
  • Execute and review batch documentation and logbooks.
  • Troubleshoot and reconcile ERP records and support material workflow management.
  • Verify area readiness and cleanroom compliance standards.
  • Collaborate with Manufacturing management, floor staff, and QA on process mitigation.
  • Mentor manufacturing personnel in partnership with management and training specialists.

Requirements

  • Bachelor’s degree in a related scientific discipline and 4 years of relevant cGMP manufacturing experience, or a high school diploma and 7 years of experience, or equivalent.
  • Prior GMP operations experience and knowledge of quality systems and regulatory expectations.
  • Strong organization and attention to detail in a fast-paced, multitasking environment.
  • Ability to work hands-on in manufacturing and cleanroom operations.
  • Knowledge of upstream microbial fermentation or downstream biopharmaceutical unit operations is preferred.
  • Excellent written and verbal communication skills are preferred.

Nice to have

  • Experience with single-use and stainless-steel platform technologies.

Culture & Benefits

  • Cross-functional collaboration with Manufacturing, QA, floor staff, and training specialists.
  • Hands-on work supporting site and department objectives.
  • Full-time employment with a fixed Monday–Friday swing-shift schedule.

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