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 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!

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 Specialist, Manufacturing Quality  to join our Operations team…

JOB SUMMARY

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

 

RESPONSIBILITIES AND LEARNING OPPORTUNITIES


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


* Work with Senior Specialist on Root Cause Analysis and proper investigations for minor OOS and Deviation cases.


* 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. 


* Support all Continuous Improvement efforts within the department.


* Support monitoring and reporting department metrics on a continual basis.


* Provide assistance to execute, track and analyze assigned projects.

Help identify any project dependencies and critical paths. 


* Effectively communicate and manage project expectations and success criteria to project sponsors, team members, vendors and other stakeholders in a clear and concise manner throughout the project lifecycle.


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


* Support Manufacturing Manager in reducing compliance risk by aiding in performing internal audits and developing action items to correct risks.


* Follow and observe all regulatory requirements (GMP’s, ISO, FDA, internal policies) applicable to area of responsibi...