Job Title: Project Coordinator III/ Product Change Control Management
Job Location: Onsite Position: Foster City – 5 days/week – Local Candidates
Job Duration: 12 Months (possibility of extension)
Payrate: $102.18/ hr. on W2
Job Summary:
- 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.
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.
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.