Quality Assurance Specialist III

4 weeks ago


Rochester, New York, United States Vyriad Full time

Job Summary

Vyriad is seeking a highly skilled Quality Assurance Specialist III to join our team. This role requires a full understanding of quality system requirements and the ability to independently lead audits, projects, and initiatives.

The successful candidate will play a key role in annual audit planning, project management, conflict resolution, and providing guidance to areas navigating compliance challenges.

Key Responsibilities

  • Oversee quality and regulatory compliance for the manufacturing operation and other business units.
  • Identify and reduce regulatory and compliance risks by continuously monitoring and evaluating facility policies and practices.
  • Lead large projects and initiatives independently, functioning as a project manager.
  • Assist areas in navigating conflict and compliance challenges.
  • Develop regulatory and compliance training programs for the intended audience.

Requirements

A bachelor's degree in a science-related field is required, and a minimum of 5 years' experience in a manufacturing quality assurance role or 3 years' experience in a biotechnology company.

Desirable Skills

Knowledge and experience in FDA current Good Manufacturing Practices for product manufacturing is required. Additional experience with other requirements (ICH, ISO, etc.) is highly desirable.

Exceptional human relations and communication skills are required.

Attention to detail-oriented and the ability to work independently and productively with minimal direction.

Self-motivated and ability to exercise sound judgment.

Strong analytic skills coupled with critical thinking skills are essential in this role.

The ability to exercise good judgment while under pressure and tight deadlines, and strong coping skills are required.

Maintains control and takes responsibility for third-party service providers (contract manufacturers, contract laboratories, etc.).

Ensures compliance concerns are prioritized and resources identified.

Works with staff to ensure compliance with regulatory requirements associated with internal and external assessments and responses to citations.

Receives, tracks, and responds to customer and regulatory complaints.

Leads the investigation of events that appear to be associated with regulatory violations.

Works with relevant parties to resolve issue and take appropriate corrective and preventive action.

Vyriad is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, genetic information, gender identity, sexual orientation, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local laws.

This policy applies to all terms and conditions of employment, including, but not limited to, hiring, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.



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