Senior Regulatory Licensing Analyst

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

• 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

Preferred

• 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.

Physical Requirements

• Prolonged sitting or standing
• Communicating with others to exchange information.

Your Working Conditions: 

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