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Project Coordinator - IT - III

Iconma

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
14 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?  

About the Company

I

Iconma

ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

  • Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
  • Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
  • Founded in 2000
  • 2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Management Consulting Services
EMPLOYEE BENEFITS
401K, Employee Referral Program, Life Insurance
FOUNDED
2000
WEBSITE
https://www.iconma.com/

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