Quality Assurance Manager

1 day ago

St Louis MO USA, United States Actalent Full time
Job Title: Quality Assurance Manager

Job Summary:

We are seeking a highly skilled Quality Assurance Manager to join our team at Actalent. As a Quality Assurance Manager, you will be responsible for developing, implementing, and maintaining quality assurance programs to ensure compliance with all regulatory requirements and industry standards.

Key Responsibilities:

  • Develop and implement quality assurance programs to ensure compliance with regulatory requirements and industry standards.
  • Conduct audits and manage documentation to ensure quality system practices are followed.
  • Liaise with site FSQA Manager to support quality system initiatives.
  • Lead continuous improvement initiatives to ensure the Quality Management System (QMS) is implemented effectively.
  • Collaborate cross-functionally to identify, develop, build, and implement QMS policies and procedures.
  • Manage and deliver projects to drive continuous quality excellence.
  • Participate, advise, and support FDA inspections, and customer audits, and support external audit response management.
  • Maintain knowledge of regulations and stay abreast of all regulatory changes relevant to the industry and organization.
  • Act as a SME supporting Quality/operations/R&D team members to ensure compliance requirements are being met during the management of change process.
  • Support a proactive approach toward investigation and resolving potential product compliance issues.
  • Develop and deliver training programs to educate staff on quality standards and procedures.

Requirements:

  • Bachelor's degree in biological or STEM-related field.
  • 5-7 years of experience in food safety and quality assurance, preferably in a food or pharmaceutical manufacturing environment.
  • Strong expertise in deviation management processes including in-depth root cause analysis and CAPA implementation.
  • Thorough knowledge and application of Good Documentation Practices (GDP).
  • Knowledge and understanding of cGMP regulations and FDA and EU requirements/guidance documents.
  • Proficiency in using quality management software and Microsoft Office Suite.

Work Environment:

This is a fully on-site position in St. Louis, Missouri.

About Actalent:

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market.

Diversity, Equity & Inclusion:

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. We maintain an inclusive environment through persistent self-reflection, building a culture of care, engagement, and recognition with clear outcomes.

Equal Opportunity Employer:

Actalent is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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