What are the responsibilities and job description for the Senior Regulatory Licensing Analyst 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 Senior Regulatory Compliance Specialist performs various functions, which primarily entails ensuring that the organization adheres with US and International standards related to Brooks Life Sciences Services operations. Works with cross-functional teams to ensure product compliance and develop processes and methodologies for tracking/reporting compliance.
What You’ll Do
Perform regulatory compliance internal audit checks to guarantee continuous regulatory compliance as directed for US and Global locations. Working knowledge of pertinent regulations, standards and guidance documents that dictate compliance qualifications (GMP/GLP/DDA/CLIA/CAP/ISO/FDA/EU/etc.) Assist with global regulatory licensing, accreditations and internal or external audits for DDA/State 3PL, FDA Tissue license, NRC radioactive license, Japanese FMA license, miscellaneous US State tissue licenses, CAP/CLIA, ISO, etc. Manage investigations and carry out root cause analysis to ascertain the cause and remedial actions. Host Federal, State, and global surveys. Assist with all activities and outcomes related to regulatory portions of CAP, GxP and compliance audits. Answer compliance-related questions to provide regulatory guidance regarding the products/services of the company, in accordance with emerging/new regulations. Assist in the scheduling, facilitating and responding to client audits.
What You Will Bring
Employee may work in an area with potentially infectious materials. Employee will be responsible for maintaining a clean work environment and enforce and follow Universal Precautions for bloodborne pathogens when working in an area considered to be potentially contaminated.
EOE M/F/Disabled/VET
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 Senior Regulatory Compliance Specialist performs various functions, which primarily entails ensuring that the organization adheres with US and International standards related to Brooks Life Sciences Services operations. Works with cross-functional teams to ensure product compliance and develop processes and methodologies for tracking/reporting compliance.
What You’ll Do
Perform regulatory compliance internal audit checks to guarantee continuous regulatory compliance as directed for US and Global locations. Working knowledge of pertinent regulations, standards and guidance documents that dictate compliance qualifications (GMP/GLP/DDA/CLIA/CAP/ISO/FDA/EU/etc.) Assist with global regulatory licensing, accreditations and internal or external audits for DDA/State 3PL, FDA Tissue license, NRC radioactive license, Japanese FMA license, miscellaneous US State tissue licenses, CAP/CLIA, ISO, etc. Manage investigations and carry out root cause analysis to ascertain the cause and remedial actions. Host Federal, State, and global surveys. Assist with all activities and outcomes related to regulatory portions of CAP, GxP and compliance audits. Answer compliance-related questions to provide regulatory guidance regarding the products/services of the company, in accordance with emerging/new regulations. Assist in the scheduling, facilitating and responding to client audits.
What You Will Bring
- Four-year degree in Life Science or equivalent years of practical work experience
- 4 years of experience in a GXP (GLP, GNP, GTP & GDP), and CLIA/CAP laboratory environment required
- Active participant in continuous improvement initiatives.
- Experience writing and managing SOP’s
- 3 years’ experience conducting CAP audits
- Experience hosting FDA or other regulatory audits
- Certified auditor training per ASQ or ISO
- 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, Excel, Word, and PowerPoint.
- Prolonged sitting or standing
- Communicating with others to exchange information.
Employee may work in an area with potentially infectious materials. Employee will be responsible for maintaining a clean work environment and enforce and follow Universal Precautions for bloodborne pathogens when working in an area considered to be potentially contaminated.
EOE M/F/Disabled/VET
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.
