IT Project Coordinator
Job Location:
Job Location:
Foster, CA - USA
Monthly Salary:
Not Disclosed
Monthly Salary:
Posted on:
12 days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Title: IT Project Coordinator
Location - Foster City CA (5 Days/ week onsite)
Duration: Long term
Location - Foster City CA (5 Days/ week onsite)
Duration: Long term
Description: 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.
Job Responsibilities:
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.
Knowledge & Skills:
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.
Education & Experience:
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.
Job Responsibilities:
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.
Knowledge & Skills:
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.
Education & Experience:
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.
