Quality Assurance Specialist III
1 day ago
Job Summary
Vyriad is seeking a highly skilled and experienced Quality Assurance Analyst III to join our dynamic team. This role requires a full understanding and knowledge of quality system requirements and the ability to independently lead audits, projects, and initiatives.
Key Responsibilities
- Lead annual audit planning, ensuring comprehensive coverage of key areas.
- Collaborate with relevant stakeholders to align audit plans with organizational goals.
- Independently conduct audits, demonstrating a high level of expertise and attention to detail.
- Provide recommendations for continuous improvement based on audit findings.
- Lead large projects and initiatives independently, functioning as a project manager.
- Ensure successful completion of projects within established timelines.
- Assist areas in navigating conflict and compliance challenges.
- Direct root cause and Corrective and Preventive Action (CAPA) investigations as needed.
- Provide knowledge and expertise to Vyriad staff on quality concepts and practices.
- Ensure risks are escalated and documented appropriately.
- Maintain control and take responsibility for third-party service providers.
- Develop regulatory and compliance training programs for the intended audience.
- Receives, tracks, and responds to customer and regulatory complaints.
- Lead the investigation of events that appear to be associated with regulatory violations.
Requirements
- A bachelor's degree in a science-related field is required.
- A minimum of 5 years' experience in a manufacturing quality assurance role or 3 years' experience in a biotechnology company.
- Knowledge and experience in FDA current Good Manufacturing Practices for product manufacturing is required.
- 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.
- Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.
Physical Requirements
Prolonged periods of sitting at a desk and working on a computer.
Must be able to lift up to 15 pounds at times.
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.
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