ApTask Global Workforce (AGW) is seeking a Project Coordinator - IT - III with a Pharmaceutical company. This is a 12+ month contract opportunity with our client located in Foster City, CA. This is Onsite position. Summary: This role will support the Device Engineering team with drug device combination products throughout their commercial lifecycle. The successful candidate will be responsible for managing combination product change records, post-market surveillance reports, and risk management file maintenance. This position acts as a key project manager for the combination product portfolio.
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
Requirements: - 3-5 years of relevant experience in a related field and a BS or BA
- Experience with medical device development and/or pharmaceutical operations (cGMP environment) required
- 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
Pay range: Up to $100.71 per Hour
Only candidates available and ready to work directly as ApTask Global Workforce (AGW) employees will be considered for this position.
If you have the described qualifications and are interested in this exciting opportunity, please apply! ApTask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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