Home   Register   Sign In
Company Info


BOSSIER CITY, LA, United States

Web Site: www.csc.com

Company Profile

Document Control Associate


Job ID:



Frederick, MD, United States 



Job Views:


Employment Type:

Full time



Job Description:

Essential Job Functions 

Maintain accurate and secure filing systems for compliance documentation to include current active/effective/published documents, inactive documents and obsolete documents inclusive of the historical information in accordance to company SOPs. 

Ensure product documentation is maintained according to CGMP, GCP and/or GLP standards and applicable regulations and guidelines. 

Maintain the agreed upon Common Technical Document (CTD) format for the preparation of well-structured applications that will be submitted to regulatory authorities. 

Support document formatting and editing functions to aid with finalization of internal documents. 


Basic Qualifications 

Job Requirements:

Bachelor's degree or equivalent combination of education and experience 

Bachelor's degree in engineering, mathematics, computer science, chemistry, physics, biology or related field preferred 

Zero or more years of experience in application and/or engineering technology development 

Experience working with relevant scientific development and engineering principles and practices 

Experience working with company products and offerings 

Experience working with the technology industry 

Experience working with mathematical, physical, chemical, biological or aerodynamic principles 

Other Qualifications 

Minimum of one year of experience in the biologics, pharmaceutical and/or medical device industry as an auditor or equivalent in a quality assurance decision-making capacity. 

Demonstrated experience working in regulated systems and documentation 

Must possess moderate knowledge of local, state and federal regulations pertaining to GXP, CGMP, GLP and GCP, in addition to Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) guidelines 

Excellent problem solving skills 

Excellent organizational skills to balance and prioritize work 

Strong interpersonal skills to interact with customers and team members 

Strong writing, editing and word processing skills 

Ability to work independently and as part of a team 

Ability to handle and follow up on multiple tasks and projects 

Ability to perform work on complex projects with minimal supervision 

Accurate and detail orientated. Ensure efficient, high quality deliverables 

© 2016 Powered by Rootjobs     About Us   Sitemap   Terms and Conditions   Privacy Policy   Mobile Version     Twitter RSS LinkedIn Facebook