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7 часов назад

Quality Compliance Specialist

68 600 - 114 300$
Формат работы
onsite
Тип работы
fulltime
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
Quality Compliance Specialist (Aseptic Pharmaceutical Manufacturing): Providing quality oversight for aseptic and terminally sterilized manufacturing operations with an accent on cGMP compliance, aseptic practices, and real-time event oversight. Focus on supporting media fills and smoke studies, maintaining inspection readiness, escalating deviations, and driving continuous improvement on the manufacturing floor.

Location: On premise in Rocky Mount, North Carolina, United States. Work schedule is 6 a.m. to 6 p.m. on a 2/2/3 rotation, including weekends, off shifts, and holidays as required. Permanent U.S. work authorization is required; visa sponsorship is not available.

Annual base salary: $68,600–$114,300, plus eligibility for a 7.5% bonus target.

Company

hirify.global operates pharmaceutical manufacturing facilities producing medicines for patients worldwide.

What you will do

  • Provide quality oversight in aseptic and terminally sterilized manufacturing areas.
  • Enforce best aseptic practices through the Aseptic Observation Program.
  • Support media fills, smoke studies, and hypercare for newly implemented aseptic processes.
  • Provide real-time quality oversight and approvals during planned and unplanned events, process simulations, and environmental control deviations.
  • Conduct GMP and inspection-readiness walkthroughs to maintain a compliant state.
  • Drive continuous improvement projects and meet Aseptic Observation Program metrics.

Requirements

  • Bachelor’s degree in a technical, science, or engineering discipline with 0+ years of experience; alternatively, an associate’s degree with 4 years of experience or a high school diploma with 6 years of relevant experience.
  • Shop-floor experience in an aseptic manufacturing facility.
  • Thorough knowledge of GMP requirements and the ability to manage multiple projects.
  • Strong oral, written, communication, presentation, and interpersonal skills.
  • Ability to remain focused under stress, identify and escalate issues promptly, and coach operators.
  • Must be authorized to work permanently in the United States; U.S. work visa sponsorship is not available now or in the future.

Nice to have

  • Pharmaceutical manufacturing experience.
  • Experience with isolator or RABS aseptic manufacturing.

Culture & Benefits

  • 401(k) plan with hirify.global matching contributions and an additional retirement savings contribution.
  • Paid vacation, holidays, personal days, caregiver or parental leave, and medical leave.
  • Medical, prescription drug, dental, and vision coverage.
  • Relocation assistance may be available based on business needs and eligibility.

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