3 дня назад
QA Supervisor - Operations - 2nd Shift (368)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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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