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3 дня назад

QA Supervisor - Operations - 2nd Shift (368)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
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
QA Supervisor - Operations - 2nd Shift (368) (Pharmaceutical Manufacturing/Quality Assurance): Establishing and maintaining quality systems for sterile injectable manufacturing at a new fill-finish facility with an accent on cGMP compliance, FDA readiness, shop-floor oversight, and batch disposition. Focus on reviewing batch records, managing deviations and CAPA, supporting validation and inspections, and leading quality operations during the Sunday–Wednesday second shift.

Location: Petersburg, Virginia, United States; onsite, Sunday–Wednesday, 1:00 PM–11:30 PM

Company

Nonprofit pharmaceutical manufacturer focused on preventing drug shortages and supplying affordable generic sterile injectable medications.

What you will do

  • Establish and maintain quality systems and compliance processes for sterile manufacturing and operations.
  • Provide shop-floor quality oversight, including real-time batch record review, batch disposition, deviation response, and corrective actions.
  • Develop and maintain SOPs, training programs, and records supporting cGMP-compliant manufacturing.
  • Review and approve equipment qualifications, validation activities, product transfers, and manufacturing documentation.
  • Support change control, CAPA, investigations, label control, laboratory control, product complaints, APQR, and quality risk analysis.
  • Lead and support operational associates, promote quality and safety mindsets, and participate in regulatory inspections.

Requirements

  • Bachelor’s degree in a scientific discipline and at least 5 years of quality or cGMP experience in the pharmaceutical industry.
  • Required experience in sterile injectable manufacturing and packaging operations.
  • Experience across the product development and commercialization lifecycle, including regulatory agency inspections.
  • Strong project management, organization, execution, interpersonal, written communication, and software skills.
  • Ability to work autonomously in a fast-paced environment and provide leadership to shop-floor associates.
  • Ability to work onsite in Petersburg, Virginia, on the second shift schedule.

Nice to have

  • Experience with Drug Enforcement Administration requirements for controlled substances.
  • Prior supervisory experience.

Culture & Benefits

  • Mission-driven work focused on improving the availability of essential medicines.
  • Collaboration across manufacturing, quality, development, and regulatory functions.
  • Drug-free workplace and equal employment opportunity environment.
  • Reasonable accommodations are available for individuals with disabilities.
  • Travel is limited but may occasionally be required.

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