8 часов назад
Compliance Specialist (QA)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Compliance Specialist (QA): Maintaining cGMP compliance and audit readiness at a pharmaceutical production unit with an accent on Annual Product Quality Reviews, regulatory requirements, and quality systems. Focus on facilitating APQR approval, coordinating compliance initiatives, supporting investigations, and preparing for FDA readiness audits.
Location: Wilson, NC, United States; onsite
Company
develops and manufactures healthcare products, including pharmaceuticals and medical technologies.
What you will do
- Identify and correct cGMP inadequacies at the production unit.
- Compile, process, and facilitate the Annual Product Quality Review in a timely manner.
- Support quality systems that maintain internal and external audit readiness and regulatory compliance.
- Review documentation, coordinate internal audits, and support event initiation and investigations.
- Coordinate compliance initiatives based on new regulations, guidance documents, and industry standards.
- Participate in multifunctional project teams and FDA readiness audits.
Requirements
- Experience or knowledge in cGMP compliance and site quality assurance.
- Ability to review quality documentation and support internal audits.
- Ability to coordinate Annual Product Quality Reviews and related compliance systems.
- Ability to support regulatory readiness, investigations, and compliance initiatives.
Culture & Benefits
- Full-time employment with an at-will employment arrangement.
- Medical, dental, and vision coverage.
- Life insurance and disability coverage.
- 401(k) with company contribution.
- Wellness program.
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