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.

 In-depth knowledge of pharmaceutical manufacturing techniques and performing root cause analysis are critical for this position.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES


* Perform investigation activities and writing deviation investigation reports supporting non-conforming (process and procedural deviation) events


* Deploy effective root cause analysis tools, such as 5-why analysis, fishbone diagrams, etc.


* Perform thorough investigations of Manufacturing non-conforming events and customer complaints that could include review of cGMP documents and historical review of the quality management system


* Perform investigations using structured root cause analysis tools (fishbone, 5 Why's, etc.) and partner with team members to determine "true" root cause


* 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.


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


* 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.


* Develop and maintain a system for...