General job description
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. The successful candidate will play a key role in annual audit planning, project management, conflict resolution, and providing guidance to areas navigating compliance challenges.
QA Analyst III’s are responsible for oversight of quality and regulatory compliance for the manufacturing operation and other business units. The staff works to identify and reduce regulatory and compliance risks by continuously monitoring and evaluating facility policies and practices to ensure compliance is built into the operational systems.
Supervisory Responsibilities
None
Duties and Responsibilities
Full Understanding of Quality System Requirements:
- Possess a comprehensive understanding and knowledge of quality system requirements.
- Stay abreast of industry best practices and evolving quality standards.
Regulatory Compliance:
- Understand the connections between the quality system and regulatory requirements.
- Ensure compliance with all applicable regulatory standards.
Independent Auditor:
- Independently conduct audits, demonstrating a high level of expertise and attention to detail.
- Provide recommendations for continuous improvement based on audit findings.
Annual Audit Planning:
- Lead the annual audit planning process, ensuring comprehensive coverage of key areas.
- Collaborate with relevant stakeholders to align audit plans with organizational goals.
Project Management:
- Lead large projects and initiatives independently, functioning as a project manager.
- Ensure successful completion of projects within established timelines.
Conflict Resolution and Compliance Challenges:
- Assist areas in navigating conflict and compliance challenges.
- Direct root cause and Corrective and Preventive Action (CAPA) investigations as needed.
Project/Assignment Follow-Through:
- Demonstrate a commitment to timely and complete follow-through on projects and assignments.
- Maintain accountability for project outcomes and deliverables.
Assistance to QA Team Members:
- Assist other QA team members with task completion as needed.
- Foster a collaborative and supportive team environment.
Other Responsibilities:
Provides knowledge and expertise to Vyriad staff on quality concepts and practices.
Ensures risks are escalated and documented appropriately.
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.
Develops regulatory and compliance training program for the intended audience. Maintains program and keeps it up to date.
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.
Education and experience 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
Required skills and/or qualifications
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 (written, verbal, and listening) 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.
Must have demonstrated capacity to comprehend complex protocols, programs, and situations.
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.
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.
