Technical Writer

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 Technical Writer to join our Technical Services Team…

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

JOB SUMMARY

The Technical Writer reports to the Director of Technical Services and Validation.

The essential job function is to assume responsibility for all documentation and procedural activities associated with commercial production and technical transfers, as well as support documentation needs of the R&D scientists.  It includes monitoring of existing documents (including, but not limited to: Batch Records, SOPs, OIMs), identifying opportunities for improvement, and implementing both process and/or procedural improvements to further the efforts in the Manufacturing group to continuously improve.  It also includes project execution within the department, such as product transfers or changes, in addition to other daily functions needed or requested by the Director of Validation and Technical Services. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:


* Provide documentation services to the Technical Services department including writing, revising, formatting, processing, filing, and maintaining documents, including electronic files.  These documents include, but are not limited to batch production records, SOPs, protocols, and reports.



* Be able to draft incident reports, investigation reports, or other quality event (QE) reports.



* Support Quality Systems for the Technical Services Department, including CAPA, Change Control, QE tracking/trending.


* Work with technical experts to identify and document appropriate Corrective Action, Preventative Action (CAPA) as needed.

Responsible for completion of appropriate CAPA documentation.


* Act as Electronic Quality Documentation Management System Subject Matter Expert (SME) for the department, assisting and training others as needed.


* Responsible for the SOP biennial review process for Technical Services, including SOP revisions within the establis...