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Project Coordinator - IT - III

ICONMA, LLC

Foster City, CA

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JOB DETAILS
SALARY
$95.71–$100.71 Per Hour
SKILLS
Biotech and Pharmaceutical, Change Control, Change Management, Contract Management, Contract Manufacturing, Cross-Functional, Current Good Manufacturing Practice (cGMP), Document Management, Documentation, Drug Development, Drug Products, File Maintenance, Health Plan, Manufacturing, Manufacturing/Industrial Processes, Medical Equipment, Product Control, Product Management, Project/Program Coordination, Project/Program Management, Regulations, Risk, Risk Management, Surveillance, Time Management
LOCATION
Foster City, CA
POSTED
13 days ago
Our client, a Biopharmaceutical company, is looking for a Project Coordinator - IT - III for their Foster City, CA location.
 
Responsibilities:
  • The Device Engineering team at client is seeking a qualified individual to support drug device combination products throughout the commercial lifecycle.
  • This individual will be responsible for the management of combination product change records.
  • Additional responsibilities include post market surveillance reports, risk management file maintenance, and general project management across the combination product portfolio.
  • Coordinate and manage combination product change control records –
  • Initiate, route, and close change records for product and manufacturing process changes.
  • Initiate, route, and close change records for the design and development of drug device combination products, including the creation and management of design control documentation.
  • Manage implementation of changes at multiple manufacturing sites and change record closures.
  • Coordinate post-market surveillance reports and risk management file updates –
  • Collate surveillance information into yearly reports.
  • Generate annual risk summaries and update risk management files.
  • Support complaint investigations and documentation.
  • Act as a central hub between cross-functional teams to ensure supply continuity.
 
Requirements:
  • Exceptional organizational and time management skills.
  • Understanding of change controls in a regulated industry.
  • Experience with project management.
  • Working knowledge of relevant US, EU, and international medical device and pharmaceutical regulations.
  • Experience with Veeva Vault.
  • Ability to work with team members, vendors, suppliers, and contract manufacturers to coordinate changes.
  • 3 – 5 years relevant experience in related field and a BS or BA.
  • Experience with medical device development and / or pharmaceutical operations (cGMP environment) required.
 
Why Should You Apply?  
 

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ICONMA, LLC