Analytical Sciences Specialist

Are you ready to join a growing, global drug development and manufacturing organization that puts people first?  Come to Adare!  We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world.  Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact and is critical to our success.  With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!t 

Join our mission at Adare!

What can Adare offer you?


* Medical/dental/vision/life – low employee premiums


* 401k with a highly competitive match


* Generous PTO, including floating holidays


* Career growth and internal opportunities


* Tuition reimbursement


* Relocation assistance


* Performance-based bonus


* Employee Recognition Programs

 

We are seeking to hire an Analytical Sciences Specialist to join our Analytical Sciences team…

If any of the below describes you, we would love to meet you! 

JOB SUMMARY

The Analytical Sciences Specialist is responsible for supporting projects by developing and maintaining documentation and tasks required to fulfill project needs as well as auditing.

This Specialist will work alongside Analytical Scientists to drive activities, accelerate timelines, offer ideas to implement future enhancements and efficiencies, and provide adequate quality oversight and expertise for the creation and review of internal quality documents.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

Lab Project Coordination


* Coordinate with the team across multiple projects to ensure that the timelines are met by communicating milestones and other deadlines within the projects.


* Implement procedural changes to existing internal systems to gain efficiencies to get products to clinical trial status earlier by working with Quality Assurance as well as other departments to implement change (i.e., participates in continuous improvement activities within the group). 

 

 

Data Auditing Support


* Audit laboratory data for correctness, completeness, and compliance with cGMPs and the company’s internal quality standards (i.e., auditing laboratory data for early through late phase CTM and Registration batches).


* As part of the stability program, audit laboratory stability data and coordinate with the Stability Department to manage the stability testing schedule.


* Follow-up with Quality Assurance and Analytical Sciences staff to facilitate any corrections to data as required.

Lab Compliance Support


* Contribute to the creation and/or review of Quality and Regulatory documents, as needed.


* Managing the action items assigned to the group in various compliance documents (e.g., Change Controls, CAPAs, and Investigations).  These ac...