Job Description

General Job Description

Vyriad is seeking a highly skilled and experienced Quality Assurance Analyst III to join our dynamic team. As a senior member of the Quality Assurance department, 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 analytic assay development and testing services. 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. Quality Assurance staff communicate and work effectively with leadership to take necessary actions to mitigate identified risks.

Quality Assurance staff are accountable for the effective implementation of the Quality Management System (QMS) and serves as the subject matter expert on the policies, processes, and procedures of the QMS by developing a broad knowledge of the practice, business, and technology as it relates to product manufacturing.

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.
• Develops and oversees the analytical systems compliance program.
• Provides knowledge and expertise to testing personnel on quality concepts and practices.
• Ensures analytical service risks are escalated to management.
• Maintains control and takes responsibility for third-party service providers (contract manufacturers, contract laboratories, etc.).
• Ensures compliance concerns are prioritized and resources identified.
• Performs review of analytical testing documents for clarity and compliance.
• Works with scientific 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.

Other Responsibilities:

• 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 control/quality assurance role.

Required skills and/or qualifications

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

• Exceptional human relations and communication (written, verbal, and listening) skills are required. Should be very detail-oriented and have the ability to work independently and productively with minimal direction, and routinely exercise initiative and 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.

Qualifications

• Bachelor’s degree in a relevant field.
• Extensive experience in quality assurance, with a proven track record in a senior role.
• In-depth understanding of quality system requirements and regulatory standards.
• Strong project management skills and experience leading large initiatives.
• Independent auditor certification and experience.

Physical Requirements

• Prolonged periods of standing at laboratory benches.
• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.

Benefits

• Group Healthcare Plan, including company paid dental and vision.
• Short- and long-term disability, life and AD&G insurance.
• Simple IRA with employer match
• Educational assistance program
• Holiday and PTO

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