Senior Quality Assurance Analyst - Biotechnology

General Job Description

We are seeking a highly skilled and experienced Senior Quality Assurance Analyst 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.

Senior QA Analysts are responsible for oversight of quality and regulatory compliance for analytic assay development and testing services ensuring the quality of our products or services meets the highest standards through continuous monitoring training and improvement initiatives. 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.

In addition to traditional QA responsibilities this role involves delivering quality training identifying areas for improvement designing and implementing quality system enhancements and fostering innovation within the quality process.

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 FollowThrough:

• Demonstrate a commitment to timely and complete followthrough 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 thirdparty 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.

Conduct routine quality training sessions for staff to ensure understanding and adherence to quality standards.

Identify areas for improvement within the quality system through the development and analysis of monitoring measuring and metrics.

Design and initiate quality system improvements to address identified areas of improvement and enhance overall quality performance.

Innovate new and effective ways to meet quality objectives promote engagement and drive continuous improvement within the organization.

Communicate improvement and innovation ideas to leadership providing recommendations and insights for strategic decisionmaking.

Maintain effective communication channels with crossfunctional teams to ensure alignment on quality goals and initiatives.

Collaborate with other departments to integrate quality processes and standards into their workflows as necessary.

Stay current with industry best practices and technological advancements to enhance the effectiveness of the quality assurance function.

Provide support during audits and regulatory inspections as needed.

Education and Experience Requirements

A bachelors degree in a science related field is required and a minimum of 8 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 (ICH ISO etc.) is highly desirable.

Attention to detailoriented and the ability to work independently and productively with minimal direction.

Selfmotivated 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.

Extensive experience in quality assurance with a proven track record in a senior role.

Indepth understanding of quality system requirements and regulatory standards.

Strong project management skills and experience leading large initiatives.

Independent auditor certification and experience preferred.

Strong understanding of quality management principles methodologies and tools.

Proven experience in delivering quality training sessions to diverse audiences.

Proficiency in data analysis and interpretation to drive quality improvements.

Excellent problemsolving skills with the ability to identify root causes and implement effective solutions.

Strong communication and interpersonal skills with the ability to effectively engage with stakeholders at all levels.

Demonstrated ability to work independently with minimal supervision while maintaining alignment with organizational goals.

Experience with quality management systems (QMS) and regulatory requirements is preferred.

Certifications such as Six Sigma Lean or Certified Quality Auditor (CQA) are a plus.

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.