Document Control Coordinator (JP4948)

Location: Thousand Oaks, CA
Date Posted: 10-31-2018
Job Title: Document Control Coordinator (JP4948)
Location: Thousand Oaks, CA
Employment Type: Contract
Duration: 12 months with likely extensions
Business Unit:  Final Product Technologies Usability Engineering 
 
‚Äč3Key Consulting is looking for a Document Control Coordinator for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA.
 
Job Summary:
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 .
 
Responsibilities include:
  • 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 Amgen 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)
  • Additional projects, as assigned;
  • Skills: ; administrative support experience; experience using MS Outlook, Word, Excel, and PowerPoint in an office setting
Top Must have Skill Sets: Solutions driven Adaptable Experience in Quality or document control Medical Device or regulated industry experience
 
Day-To-Day Responsibilities: Draft, or Review, also manage EDMQ workflows for Protocols, Studies, Reports, Technical Assessments as needed. Building and supporting maintenance of Usability Engineering File by program/ platform Support regulatory submissions, design review deliverables, and RTQs Build data management system for storage and archival of HF studies Data Verify controlled documents.
  
Why this position is open: Supplement additional workload on team
 
Employee Value Proposition: This team has a responsibility is to assure that the use of the product/device is safe, fully vetted and de-risked. Their main focus is to help the users want to use the device. Learning and understanding human factors is quickly growing role in this industry so this opportunity will position the candidate for a successful future.
 
Red Flags: Too many jobs No medical device or regulated industry experience Typos, spelling errors in resume
 
Interview Process: Phone screen - with 3 HF staff members Onsite interviews 1/2 day
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.**No Third-party Vendors Please**
.
 
 
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
or
this job portal is powered by CATS