QA Analyst III

2 months ago

Rochester, United States Vyriad Full time

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.

  • QA Analyst III

    2 weeks ago

    rochester, United States Vyriad Full time

    General job descriptionVyriad 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,...

  • QA Analyst III

    2 weeks ago

    Rochester, United States Vyriad Full time

    General job descriptionVyriad 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,...

  • QA Analyst III

    4 weeks ago

    rochester, United States Vyriad Full time

    General job descriptionVyriad 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,...

  • Data Quality Analyst

    2 weeks ago

    Rochester, New York, United States University of Rochester Full time

    Job SummaryThe University of Rochester is seeking a highly skilled Data Quality Analyst to join our team. As a Data Quality Analyst, you will be responsible for maintaining and updating transplant quality databases, conducting quality improvement projects, and serving as a transplant quality assurance liaison.Key ResponsibilitiesCoordinate the development,...

  • Data Quality Analyst

    2 weeks ago

    Rochester, New York, United States University of Rochester Full time

    Job Title: Data Quality AnalystJob Summary:The Data Quality Analyst will be responsible for maintaining and updating the transplant quality databases, conducting quality improvement projects, and serving as the transplant quality assurance liaison. This role will involve working with the clinical team to gather and analyze data, prepare reports, and...

  • Quality Assurance Analyst

    1 month ago

    Rochester, United States Meet Full time

    My client is seeking a dynamic and hands-on Quality Assurance Analyst to lead and manage our QA activities. As a key member of our small, agile team, you will be responsible for ensuring the highest quality standards are met.Key Responsibilities:Partner with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain...

  • Quality Assurance Analyst

    1 month ago

    rochester, United States Meet Full time

    My client is seeking a dynamic and hands-on Quality Assurance Analyst to lead and manage our QA activities. As a key member of our small, agile team, you will be responsible for ensuring the highest quality standards are met.Key Responsibilities:Partner with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain...

  • Quality Assurance Analyst

    2 months ago

    Rochester, United States Meet Full time

    My client is seeking a dynamic and hands-on Quality Assurance Analyst to lead and manage our QA activities. As a key member of our small, agile team, you will be responsible for ensuring the highest quality standards are met.Key Responsibilities:Partner with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain...

  • Quality Assurance Specialist III

    2 weeks ago

    Rochester, New York, United States Vyriad Full time

    Job SummaryVyriad 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 ResponsibilitiesLead annual audit planning, ensuring comprehensive coverage of...

  • Build Specialist

    1 month ago

    Rochester, New York, United States Unlimited Technology Full time

    Job Title: Build AnalystUnlimited Technology is seeking a highly skilled Build Analyst to join our team. As a Build Analyst, you will play a critical role in overseeing the ICT build and release process for our clients.Key Responsibilities:Collaborate with Infrastructure Managers, designers, and QA Test Teams to ensure the successful execution of the build...

  • Clinical Trials

    2 weeks ago

    rochester, United States Meet Full time

    My client is seeking a dynamic and hands-on Quality Assurance Analyst to lead and manage our QA activities. As a key member of our small, agile team, you will be responsible for ensuring the highest quality standards are met.Key Responsibilities:Partner with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain...

  • Enterprise Architect I/II/III

    1 week ago

    Rochester, New York, United States Excellus BlueCross BlueShield Full time

    Job Summary:The Enterprise Architect at Excellus BlueCross BlueShield provides expertise in one or more technology, business, or continuum process disciplines within the Chief Technology Office. This role involves strategy, standards, architecture process, and consulting. The core disciplines and areas of focus are Business, Integration, Data, Application,...

  • Enterprise Architect I/II/III

    2 weeks ago

    Rochester, New York, United States Excellus BlueCross BlueShield Full time

    Job Summary:The Enterprise Architect provides expertise in one or more technology, business, or continuum process disciplines within the Chief Technology Office. This role involves strategy, standards, architecture process, and consulting. The core disciplines and areas of focus are Business, Integration, Data, Application, Technology, and Continuum...

  • Quality Analyst I

    4 weeks ago

    Rochester, New York, United States Quidel Corporation Full time

    The OpportunityQuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry, and transfusion medicine. We are a global organization with a presence in over 130 countries, providing fast,...

  • Software Quality Assurance Engineer

    1 week ago

    Rochester, New York, United States OneStream Software Full time

    About the RoleThe Software QA Engineer will be responsible for ensuring the quality of our enterprise software solutions. This includes testing, reviewing, and critiquing acceptance test plans, as well as transforming requirements into solid test cases. The ideal candidate will have a strong background in Microsoft technologies and experience working in a...

  • ThingWorx Platform Architect

    1 month ago

    Rochester, New York, United States TEPHRA Full time

    Job Title: ThingWorx Solution ArchitectWe are seeking a highly skilled ThingWorx Solution Architect to join our team at TEPHRA. As a key member of our team, you will be responsible for designing and implementing analytics and IoT solutions for the Med Device sector using the PTC ThingWorx platform.Key Responsibilities:Develop expertise in PTC products and...

  • ThingWorx Platform Expert

    7 days ago

    Rochester, New York, United States TEPHRA Full time

    Job SummaryWe are seeking a highly skilled ThingWorx Solution Architect to join our team at TEPHRA. The ideal candidate will have extensive experience in designing and implementing analytics and IoT solutions using the PTC ThingWorx platform.Key ResponsibilitiesDevelop extraction and mashup functionality to extract metadata attribute values from multiple...

  • Senior Software Quality Assurance Engineer

    2 weeks ago

    Rochester, Michigan, United States OneStream Software Full time

    About the RoleThe Senior Software Quality Assurance Engineer will be responsible for testing enterprise software solutions, reviewing and writing acceptance test plans, and transforming requirements into solid test cases. This role requires a strong background in Microsoft technologies and the ability to work as a key member in a software engineering team...

  • Enterprise Architect I/II/III

    1 week ago

    Rochester, New York, United States Excellus Health Plan Inc. Full time

    Job Description:Summary:The Enterprise Architect plays a pivotal role in shaping the strategic direction of the Chief Technology Office at Excellus Health Plan Inc. This position requires expertise in one or more technology, business, or continuum process disciplines, driving strategy, standards, architecture process, and consulting. The core disciplines and...

  • Field Inspection Specialist

    3 weeks ago

    Rochester, New York, United States ICF Full time

    Job Title: Field Inspection Specialist - Insulation and Air Sealing Energy Efficiency ProgramsICF is seeking a highly skilled Field Inspection Specialist to join our energy efficiency team in New York State. As a Field Inspection Specialist, you will play a critical role in ensuring the quality of our energy efficiency programs by conducting...