Supervisor, Documentation

Our Company

We are a $75 million, rapidly growing pharmaceutical manufacturer with strong lines in hospital and ophthalmic markets, and many new products in development and awaiting FDA approval. In anticipation of long-term, substantial growth, we offer challenging, attractive career opportunities along with competitive salaries and comprehensive benefits. Akorn is an Equal Opportunity Employer. M/F/V/D.



Job Description


We seek a Supervisor, Documentation, who will be based in our Manufacturing facility located in Somerset, New Jersey.  The successful candidate will have established a proven track record of documentation management.  This position serves as the dedicated management resource for the development, implementation and maintenance of controlled documentation and documentation systems. Primary responsibilities include associated documentation, systems and activities, provide support for all facets of material, process and product development, validation, manufacture, testing, storage, service and distribution.  He/she will also be responsible for controlled documentation associated with employee training, facility/utility/equipment description, calibration and maintenance, as well as associated documentation processing mechanisms (e.g. change control, archiving, storage, etc).   

Job Qualifications


The successful candidate will hold a Bachelor’s degree plus three or more years related managerial or supervisory experience in the pharmaceutical industry, in a documentation processing or related discipline.  Must be detail oriented, have accomplished skills in computer-assisted documentation systems and have a team work attitude.  Must also have GMP experience in an FDA related environment, inclusive of 21 CFR Part 11 compliance criteria. 

 

 

Please visit us online at https://home.eease.com/recruit/?id=36321 to apply for this position.