Skip to main content

This job has expired

You will need to login before you can apply for a job.

QA EDMS Document Controller

Employer
CSL Behring
Location
Holly Springs, North Carolina
Start date
Jan 23, 2022

View more

Discipline
Administration, Accounting, Quality
Required Education
Bachelors Degree
Position Type
Full time

Job Details

Job Description

Job Purpose:

Supports the maintenance of global quality system processes, procedures and operational activities related to Quality Assurance oversight of the Document and Records Management Systems which includes, but is not limited to, Document Management, Application of Global Quality Policies & Standards.  Provide EDMS technical support, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the Seqirus Quality Manual requirements.

Major Accountabilities:
  • Perform as EDMS Document Coordinator including:
    • workflow and effective document management for Controlled Documents
    • contact for technical questions relating to the use of EDMS
    • notifying staff of new, revised and withdrawn controlled documents
    • troubleshooting workflows and report generation
    • formatting when required
    • Periodic review workflows, reporting and support
    • Projects to support the EMDS system, e-Archive System or Quality department
  • Support site and function audit preparations with respect to EDMS/eArchive functionality.
  • Supports Seqirus EDMS. Participates in aligning change to Global Quality strategies and direction. No budget responsibility
  • General knowledge of regulatory requirements for the pharmaceutical, biotechnology or vaccine industry.
  • Ability to analyze issues and problem solve to support decision making
  • Excellent interpersonal effectiveness, written/verbal communication, influencing and negotiation skills
  • Excellent computer skills and advanced knowledge of Quality Systems.  Direct experience with TrackWise, EDMS systems and Microsoft Office including Word and Excel.
  • Self-motivator with the ability to follow-up on and complete multiple projects simultaneously.
Minimum Qualifications:
  • Bachelor degree in Engineering, Business or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.)
  • 0-2 years’ experience working in a cGMP regulated environment

About Us

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

Do work that matters at Seqirus!

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Company info
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert