Packaging Documentation Coordinator

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 Packaging Documentation Coordinator to join our Packaging Team…

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

JOB SUMMARY

The Packaging Documentation Coordinator reports to the Associate Director of Packaging.

The Coordinator will assume responsibility for all documentation and procedural activities associated with commercial production including monitoring of existing documents (including, but not limited to: Batch Records, SOPs, OJT’s/OIMs), identifying opportunities for improvement, and implementing both process and/or procedural improvements to further the efforts in the Packaging group to continuously improve.  It also includes project execution within the department, in addition to other daily functions needed or requested by management.

ESSENTIAL DUTIES AND RESPONSIBILITIES:


* Provide documentation services to the Packaging department including writing, revising, formatting, processing, filing of documents which include batch records, protocols, SOPs, etc.

This includes the maintenance of electronic files.


* Provide support for Operational Excellence tracking documents for the department, including formatting, printing, and updating as necessary.


* Support Quality Systems for the Packaging 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.


* Act as a Veeva Subject Matter Expert (SME) for the department, assisting and training others as needed.


* Responsible for the SOP biennial review process for Packaging, including SOP revisions within the established timelines, as needed.


* Perform all aspects of logbook maintenance, including creation, review, retirement, and filing functions.


* Responsible for preparation of the Packaging Section for Annual Product Reviews (APRs), including data collection, document p...