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Project Coordinator - IT - III*
Job
Mindlance
Foster City, CA (In Person)
$156,000 Salary, Full-Time
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Job Description
Project Coordinator
- IT•III•#26-15521 $70•80 per hour Foster City, CA Onsite Job Description
Onsite Position:
Foster City- 5 days/week
Local Candidates Bill Rate:
- /hr•The Device Engineering team at •is seeking a qualified individual to support drug device combination products throughout the commercial lifecycle.
- Coordinate and manage combination product change control records
- o Initiate, route, and close change records for product and manufacturing process changes. o 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. o Manage implementation of changes at multiple manufacturing sites and change record closures.
- Coordinate post-market surveillance reports and risk management file updates
- o Collate surveillance information into yearly reports. o 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.
EEO:
"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of- Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.