Document Control Specialist
Position Description
Reporting to the Sr. Director of QA, the Document Control Specialist will coordinate the flow of GXP documentation and maintain documentation systems. Responsibilities include but are not limited to:
Responsibilities include but are not limited to:
- General:
- Process documents through the Document Control system, track document status, and ensure that documents move towards approval in a timely manner
- Update Document Control procedures as necessary
- Update and maintain the Document Control paper files
- Update and maintain the Document Control electronic files and become a SharePoint power user
- Interface with Jennerex subsidiaries (Ottawa, South Korea) and Contract Manufacturing and Testing Organizations to ensure the timely and correct flow of GXP documentation
- Maintain the Jennerex Training files
- Log Change Requests (Excel) and maintain the change control system files
- Log Non-Conforming Material and Event Reports (deviations, investigations, CAPA) (Excel) and maintain the NCME system files
- Log audits (Excel) and maintain the QA audit and vendor files
- Support document archiving for Regulatory Affairs as requested
- Support Clinical Document Control needs as requested
Qualifications:
- High School Diploma required with 5+ years of related experience
- College coursework or degree is desirable with 3+ years of related experience
- Required Computer Skills: Microsoft Office (Word, Excel, Outlook, PowerPoint, InfoPath), Microsoft SharePoint, Adobe Acrobat Reader
- Desirable Computer Skills: Adobe Acrobat Professional, Microsoft Access & Project, knowledge of Electronic Document Management Systems and document workflows
Salary:
Competitive compensation package commensurate with experience
Please submit your resume to: [email protected]
YYour resume is very important to us. In order to process your resume in the most efficient manner possible, Jennerex strongly encourages you to apply online. It is not necessary to send a back-up hard copy resume. Thank you for your cooperation with our process and, most importantly, your interest in Jennerex.
