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.

All we accomplish is grounded in our core values of Customer Focus Achievement Accountability Teamwork Employee Value and Integrity

Job Description

At Azenta new ideas new technologies and new ways of thinking are driving our future. Our customerfocused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.

Azenta Life Sciences is aglobal leader in the life sciences space with headquarters in Burlington MA and offices and operations worldwide. We area market leader in automated bio sample management solutions and genomic services across areas such as drug development clinical and advanced cell therapies for the industrys 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 Youll 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 crossfunctional teams to ensure product compliance and develop processes and methodologies for tracking/reporting compliance.

What Youll 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 compliancerelated 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

• Fouryear 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 SOPs
• 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

If any applicant is unable to complete an application or respond to a job opening because of a disability please email at for assistance.

Azenta is an Equal Opportunity Employer. This company considers candidates regardless of race color age religion gender sexual orientation gender identity national origin disability or veteran status.