Quality Associate I (Q and V)
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The Opportunity
Description
We're looking for a Quality Associate I (Q and V), working in Pharmaceuticals and Medical Products industry in 5000 Davis Drive, Durham, North Carolina, 27709, United States.- Coordination/liaison with external parties related to sample management, shipment, analytical test results and reports.
- Tracking and communication of status of analytical results and reports, including ability to detect related schedule delays impacting the projects.
- Comfortable analyzing scientific datasets/strong analytical skills with excellent written skills.
- Provide technical expertise to the clinical and PPQ manufacturing campaigns run at the RTP manufacturing site in collaboration with a partner company
- Provide project management, technical/operational relationship management, and knowledge management of manufacturing processes.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- Data management experience, good communication and
project management skills.
- Solid technical understanding of either upstream and
downstream, including transfer of such processes into full-scale manufacturing
facilities
- Knowledge of cGMP, FDA/EMA regulations, Process
Performance Qualification
- Strong analytical skills with excellent written skills
- Proficiency with all MS Office applications, particularly
MS Project, MS SharePoint, and MS Excel. Basic programming capabilities
(Python, SQL, etc.), while not required, are a big plus.
- Proficiency with Laboratory Information Systems (LIMS, e.g., LabWare).
Education:
- Bachelor’s degree chemical engineering, biochemistry,
bioengineering, biology, or similar, 2+ years’ experience
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
Apply Now
