What are the responsibilities and job description for the Quality Associate position at Azenta Life Sciences?
At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer-focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.
Azenta Life Sciences is a global leader in the life sciences space with headquarters in Burlington, MA, and offices and operations worldwide. We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally. We provide unparalleled capabilities with our lab analysis, sample management and storage services, informatics software, and consumables, with the largest installed base managing over 1 billion samples globally.
How You’ll Add Value
The Quality Associate will create and implement policies and procedures which result in attaining quality goals and GxP requirements. They will be expected to comply with, enforce and be held accountable for all GxP Practices and Quality Control Procedures.
What You’ll Do
Responsible for assisting in the scheduling, facilitating and responding to client audits. Work with other functional areas and appropriate resources to develop and implement appropriate Quality policies. Performs internal audits. Reviews data change controls prior-to and post-implementation. Reviews equipment validation documents including, but not limited to, freezer mapping and remote alarm monitoring systems. Assists with implementation of quality system in global branches of Azenta Life Sciences. Maintain department records, answers telephone, correspondence, performs clerical duties. Requisitions supplies, equipment and forms needed in the department. Performs other duties as directed by the Quality Management.
What You Will Bring
Azenta Life Sciences is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer.
Azenta Life Sciences participates in E-Verify®, and will provide the United States Federal Government with your form I-9 information to confirm you are authorized to work in the United States. For more information, please visit E-Verify® at www.dhs.gov/E-Verify. E-Verify® is a registered trademark of the U.S. Department of Homeland Security.
Azenta Life Sciences is a global leader in the life sciences space with headquarters in Burlington, MA, and offices and operations worldwide. We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally. We provide unparalleled capabilities with our lab analysis, sample management and storage services, informatics software, and consumables, with the largest installed base managing over 1 billion samples globally.
How You’ll Add Value
The Quality Associate will create and implement policies and procedures which result in attaining quality goals and GxP requirements. They will be expected to comply with, enforce and be held accountable for all GxP Practices and Quality Control Procedures.
What You’ll Do
Responsible for assisting in the scheduling, facilitating and responding to client audits. Work with other functional areas and appropriate resources to develop and implement appropriate Quality policies. Performs internal audits. Reviews data change controls prior-to and post-implementation. Reviews equipment validation documents including, but not limited to, freezer mapping and remote alarm monitoring systems. Assists with implementation of quality system in global branches of Azenta Life Sciences. Maintain department records, answers telephone, correspondence, performs clerical duties. Requisitions supplies, equipment and forms needed in the department. Performs other duties as directed by the Quality Management.
What You Will Bring
- Four-year degree in Life Science/Engineering.
- Experience in Good Laboratory Practices, Good Manufacturing Practices or Good Tissue Practices facility.
- Exposure to biological safety policies and guidelines.
- Experience in the areas of Quality Improvement and Quality Assurance.
- Preferred
- 1 year minimum of Azenta Life Sciences experience.
- Active participant in continuous improvement initiatives.
- Experience writing and managing SOP’s and Quality Assurance and Business Policies.
- Experience with FDA and/or customer audits in an FDA regulated environment.
- Strong analytical skills and the ability to think creatively.
- Excellent leadership skills and ability to work across organization.
- Strong communication and interpersonal skills.
- Demonstrated high level of initiative and ability to work independently.
- Proven ability to work effectively with teams.
- Competency with Microsoft Office products including Outlook, Word and PowerPoint.
- Onsite - Indianapolis (aligned to company policy 4 days in office)
- Employee may occasionally work in an area with potentially infectious materials.
Azenta Life Sciences is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer.
- As an Equal Opportunity Employer, we do our utmost to ensure that there is no discrimination or bias against anyone applying for a job or in any phase of employment for reasons related to race, color, religion, gender, national origin or ancestry, age, disability, veteran status, military service, sexual orientation, genetic information, or gender identity.
Azenta Life Sciences participates in E-Verify®, and will provide the United States Federal Government with your form I-9 information to confirm you are authorized to work in the United States. For more information, please visit E-Verify® at www.dhs.gov/E-Verify. E-Verify® is a registered trademark of the U.S. Department of Homeland Security.
- The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
