Documentation Specialist

Company: Ampcus, Inc.
Location: Greenville
Posted on: March 16, 2023

Job Description:

Title: Documentation Specialist Duration: 3/20/23-12/19/23 Work Site Location: Greenville, NC 27834 Description: This position provides administrative support for commercial batch record review, Master Control documents, training modules and the electronic Quality Management System (eQMS). Responsibilities include, but are not limited to: --- Perform review of executed commercial batch records to ensure quality and accuracy --- Partner with commercial supervisors and operators to handle corrections and/or discrepancies within executed commercial records --- Author and format SOPs, Impact Reviews and Change Controls within Master Control; ensure documentation formatting is consistent, accurate and harmonized --- Ensure the documentation database is accurate and inputs conform to company standards --- Provide requested information during client and FDA audits --- Ensure all errors and corrections are resolved according to SOP requirements --- Enter data into applicable spreadsheets/database --- Participate and contribute to the continued implementation of electronic document software systems Education or Equivalent Requirements: --- Bachelor's degree with at least 1 year of relevant experience --- Associate degree with at least 3 years of relevant experience --- High school diploma or equivalent with at least 4 years of relevant experience --- Previous documentation control and management required --- Proficient with Microsoft Office Word and Excel and Adobe Professional --- Experience with database management software Physical Requirements: --- Using a computer and sitting for long periods of time --- Requires the capacity to handle and manipulate objects using hands and arms

Keywords: Ampcus, Inc., Greenville , Documentation Specialist, Other , Greenville, North Carolina