Quality Assurance Specialist III

1 day ago

Rochester, New York, United States Vyriad Full time

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.

  • Quality Assurance Specialist

    3 weeks ago

    Rochester, New York, United States Insight Global Full time

    Quality Assurance Specialist OpportunityInsight Global is seeking a skilled Quality Assurance Specialist to join their team at a leading biotech company in Rochester, Minnesota. The ideal candidate will have a strong background in GxP and/or Clinical Laboratory Improvement Amendments (CLIA) experience.Key Responsibilities:Implement and maintain ISO 9001...

  • Quality Assurance Specialist

    1 month ago

    Rochester, New York, United States New York Technology Partners Full time

    Job Summary:New York Technology Partners is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services, and for implementing processes to improve our quality management system.Key Responsibilities:Quality Control: Conduct regular...

  • Quality Assurance Specialist

    1 day ago

    Rochester, New York, United States Aleron Full time

    Quality Assurance SpecialistAcara Solutions is seeking a Quality Assurance Specialist to join our client on a Full Time Direct Hire opportunity located in Rochester, NYHourly pay is $ an hour plus a $1.25 dollar shift differentialCome join this leading vertically integrated medical device manufacturing platform partner of the world's most recognized and...

  • Quality Assurance Specialist

    10 hours ago

    Rochester, New York, United States PMB Talent Partners Full time

    Job Overview:We are seeking a highly skilled Quality Assurance Specialist to join our team.The ideal candidate will have a strong attention to detail and be able to inspect and sort products during the manufacturing process.Key Responsibilities:Perform final visual and mechanical inspections of products to ensure quality and accuracy.Interpret written...

  • Quality Assurance Specialist

    1 day ago

    Rochester, New York, United States Endo Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Endo. The successful candidate will be responsible for monitoring, tracking, and trending Non-Conformances, CAPA, Complaints, and other quality systems.Key ResponsibilitiesAssess the risk level associated with Non-Conformances and escalate the issue to...

  • Quality Assurance Specialist for Product Development

    4 weeks ago

    Rochester, New York, United States Galaxy Group Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Galaxy Group. As a Quality Assurance Specialist, you will play a crucial role in ensuring the conformity of our products and prototypes with relevant regulations and standards.Key ResponsibilitiesAccompany product and prototype development, as well as customer...

  • Quality Assurance Specialist

    6 hours ago

    Rochester, New York, United States Tad PGS Full time

    Job Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Tad PGS. As a 3rd Shift Inspector, you will be responsible for ensuring the quality of our products by conducting inspections and testing. This is a unique opportunity to work with a leading company in the Rochester, NY area.Key Responsibilities: Conduct inspections...

  • Quality Assurance Specialist

    3 weeks ago

    Rochester, New York, United States Lifetime Assistance Full time

    Job SummaryWe are seeking a highly skilled and detail-oriented Quality Assurance Associate to join our team at Lifetime Assistance. As a Quality Assurance Associate, you will be responsible for investigating incidents, reviewing incident reports, and determining the direction of the investigation. You will also be responsible for conducting interviews,...

  • Quality Assurance Specialist

    3 weeks ago

    Rochester, New York, United States TalentBridge Full time

    Quality Assurance EngineerAt TalentBridge, we are seeking a skilled Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will play a critical role in ensuring the quality and reliability of our software solutions.Responsibilities:Develop and execute test plans for complex systems, working closely with cross-functional teams to...

  • Quality Assurance Specialist

    1 week ago

    Rochester, New York, United States TalentBridge Full time

    Quality Assurance EngineerAt TalentBridge, we are seeking a skilled Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will play a critical role in ensuring the quality of our software solutions.Responsibilities:Develop and execute test plans for complex systems, working closely with cross-functional teams to identify and...

  • Quality Assurance Specialist

    1 week ago

    Rochester, New York, United States New York Technology Partners Full time

    Quality Engineer - CMMWe are seeking a highly skilled Quality Engineer to join our team at New York Technology Partners. As a Quality Engineer, you will play a critical role in ensuring the quality of our products and services.Key Responsibilities:Create inspection sheets and determine process dimensions for multiple operations and outside services.Develop a...

  • Quality Assurance Specialist

    2 days ago

    Rochester, New York, United States Kelly Services Full time

    Job SummaryKelly Services is seeking a Quality Technician to join our team. As a key member of our quality assurance team, you will play a crucial role in improving the overall effectiveness of our Quality Management System (QMS) and supporting continuous improvement initiatives.This role involves conducting visual inspections, performing audits, and...

  • Quality Assurance Specialist

    3 weeks ago

    Rochester, New York, United States Kelly Full time

    Quality Inspector Job DescriptionKelly is seeking a Quality Inspector to join our team in Rochester, NY. As a Quality Inspector, you will be responsible for ensuring the quality of products and services by conducting inspections and audits.Key Responsibilities:Conduct visual quality inspections and finished product auditsReview job tickets for specifications...

  • Quality Assurance Specialist

    4 weeks ago

    Rochester, New York, United States Unlimited Technology Full time

    Job Title: Quality Assurance AnalystAt Unlimited Technology, we are seeking a highly skilled Quality Assurance Analyst to join our team. As a Quality Assurance Analyst, you will play a critical role in ensuring the quality of our software products and services.Key Responsibilities:Monitor software quality and associated business/technical risks in support of...

  • Quality Assurance Specialist

    2 days ago

    Rochester, New York, United States Lifetime Assistance Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Associate to join our team at Lifetime Assistance. The successful candidate will be responsible for investigating incidents, reviewing incident reports, and determining the direction of the investigation. They will also be responsible for conducting interviews, writing detailed investigation...

  • Quality Assurance Specialist

    3 weeks ago

    Rochester, New York, United States Integrated Security Technologies Full time

    Quality Assurance Analyst Job DescriptionAt Integrated Security Technologies, we are committed to delivering cutting-edge technology solutions to meet our customers' evolving needs. As a Quality Assurance Analyst, you will play a critical role in ensuring the quality and reliability of our software applications.Key Responsibilities:Monitor software quality...

  • Quality Assurance Specialist

    4 weeks ago

    Rochester, New York, United States Brothers International Full time

    {"h1": "Quality Assurance Associate", "p": "At Brothers International, we are passionate about creating high-quality food products that enrich lives and bring people together. As a Quality Assurance Associate, you will be part of a dynamic team that ensures food and ingredients from all divisions follow applicable authorities and that our customers receive...

  • Quality Assurance Specialist

    1 month ago

    Rochester, New York, United States Syntec Optics Full time

    Job SummaryAs a Quality Inspector at Syntec Optics, you will be responsible for conducting quality assurance audits and routine checks, tests, gauging, and instrument inspections of materials, work in process, and finished product. You will ensure that company and product standards are maintained and product integrity is preserved. You will consult with the...

  • Quality Assurance Specialist

    1 day ago

    Rochester, New York, United States New York Technology Partners Full time

    Quality Engineer Job Description **Job Summary:** We are seeking a highly skilled Quality Engineer to join our team at New York Technology Partners. As a Quality Engineer, you will be responsible for ensuring the quality of our products and services. **Key Responsibilities:** * Create inspection sheets and determine process dimensions for multiple...

  • Customer Quality Assurance Specialist

    2 days ago

    Rochester, New York, United States Zobility Full time

    Quality Assurance Expert WantedWe are seeking a highly skilled Quality Assurance Expert to join our team at Zobility, a leading workforce management and staffing division of RGBSI. As a Quality Assurance Expert, you will play a critical role in ensuring the highest quality standards are met in our automotive and electromechanical technology business.Key...