Document Control Coordinator (JP8207)
Thousand Oaks, CA. (Remote until Covid-19 restrictions are lifted)
Drug Substance Quality Assurance
12 months with likely extensions
3 Key Consulting is hiring a Document Control Coordinator
for a consulting engagement with our client, a leading global biopharmaceutical company.
Responsible for the maintenance of all required documentation for the company. Provide services to maintain and control Master Record documents. Responsible for word processing and distribution of documents and maintenance of document files in a confidential and secure manner. Provide comprehensive administrative services to coordinate and maintain Good Manufacturing Practices (GMP). Manage release and control of updates to documents. Control distribution of new releases and recall/destruction of obsolete documents
- Archive documentation organization, data entry, lifting and moving of boxes; must be able to lift up to 50 lbs.
- Scanning and loading of documents into the Electronic Document Management System.
- Follow step-by-step instructions and perform repetitive functions consistently and accurately.
- Act as department representative to communicate and educate clients on DMS processes, answer general questions, troubleshoot problems, and complaint resolution.
- Work both independently and in a team environment.
- Metrics reporting using Excel tables and charts.
- Follow Current Good Manufacturing Practices (cGMP) regulations and company policies and procedures.
- Work in a rapidly changing and demanding environment.
- Strong attention to detail, including the ability to proofread documents.
- Basic understanding of the cGMPs, as related to document requirements.
- Controlled document and batch record documentation filing.
- Create and maintain interdepartmental training manuals (instructions).
- Provide training for users.
- Support audits and inspections.
- Additional projects as assigned.
Strong communication skills, administrative support experience; experience using MS Outlook, Word, Excel, and PowerPoint in an office setting
Top Must-Have Skill Sets:
Employee Value Proposition:
- Strong Communication Skills
- Strong Excel skills
- 1+year of Document Control experience
- Document Management/ administrative support experience
Great networking with different departments and functional levels.
Lack of relevant experience, multiple errors demonstrating lack of attention to detail
Video - interview with hiring manager and Quality Systems director
We invite qualified candidates to send your resume to firstname.lastname@example.org
. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also to share this opportunity with anyone you think might be interested in applying for this role.