About the job
The Document and Training Specialist is a quality and people focused individual who ensures documentation and record keeping processes conform to cGMP and regulatory requirements as well as Fagron Internal policies.
Essential Functions include at a minimum:
• Performs QA document control functions, including document logging, tracking, processing, review,
distribution, release and archiving of documents. Manages and maintains MasterControl Document and
Training Modules
• Coordinates the revision, review, and approval and obsoleting of SOPs, Work Instructions, Lab Methods,
Methods of Manufacture, and other GMP documents. Responsible for ensuring area managers perform
annual review of all cGMP documents and SOPs.
Advises and responds to queries on effecting changes to documents by interfacing with document
owners and originators of changes, providing prior and current revisions of documents, and running
queries and reports.
• Organizes and ensures accurate and reliable filing systems for all GMP documents including
management of off-site record storage.
• Maintains training programs including training matrix, training files and annual audit of training files.
Track all trainings, schedule training sessions within required timeframes and file training
acknowledgements.
Acts as in –house training “consultant” for management and staff designing training programs or
processes.
Set yourself apart
Job Requirements:
Bachelor’s Degree in a Scientific field or Bachelor’s of Arts with related experience in a scientific field.
3-5 Years experience in QMS for a cGMP regulated organization
Significant professional experience with documentation creation and editing skills using MS Office applications
Must possess excellent project management and organizational skills.
Excellent interpersonal, verbal, and written communication skills, with the ability to clearly and effectively present complex and technical materials to internal and external audiences.
Proven ability to effectively communicate and interact with individuals throughout all levels of an organization
What’s on offer?
Fagron US offers its associates competitive compensation and a wide range of benefits including a 401(k) plan with a generous company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.