Senior Specialist, Manufacturing Quality

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.  Every role within Adare offers you a unique, customized experience with a chance to make a real impact that is critical to our success.  With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!

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 a Senior Specialist, Manufacturing Quality to join our Operations team…

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

JOB SUMMARY

The Senior Specialist, Manufacturing Quality is a critical member of the Operations team, responsible for all documentation and procedural activities associated with non-conformance investigation reports and actions that come out of the reports.  This includes investigation, analysis, and writing of non-conformances and the associated reports.

The job function is also to identify opportunities for improvement, and implementing both process improvements to further the efforts in the Manufacturing group.

It also includes project execution within the department, in addition to other daily functions needed.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES


* Provide documentation services to the Manufacturing department including writing, revising, formatting, processing, filing, and maintaining documents, including electronic files.


* Support all Quality Systems for the Manufacturing Department, including CAPA, Change Control, NCIR tracking/trending.


* Support and promote Safety and cGMP programs, ensuring strict conformance to all current FDA and cGMP guidance and guidelines.


* Review, update and approve Standard Operating Procedures (SOPs) and other official documents. 


* Support Quality Systems for the Manufacturing Department, including CAPA, Change Control, NCIR tracking/trending.


* Identify appropriate Corrective Action, Preventative Action (CAPA) as needed.

Responsible for completion of CAPA and follow-up on effectiveness.


* Support all Continuous Improvement efforts within the department.


* Aid in support and help maintain a system for pre-campaign activities for all manufacturing processes.


* Develop and maintain a system for monitoring and reporting department metrics on a continual basis.


* Develop, plan, track and analyze assigne...