Quality Assurance Senior Specialist @ * Specialized in biologic product manufacturing deviation management in downstream processing, i.e. sterile fill, freezing, final container closure and packaging.
* Actively managed CAPAs implementation and follow-up effectiveness checks.
* Expert in Biotech manufacturing technology, process, validation, and change control systems.
* Member of American Society of Quality (ASQ) and Regulatory Affairs Professional Society (RAPS).
* ASQ certified Pharmaceutial GMP Professional. From April 2015 to Present (9 months) Senior Product Specialist, Hematology @ • Deep knowledge and hands-on experience with development and commercial biologics product processing, including GxP compliance, validation, change control, QA deviation management, etc.
• Proven leadership track record in facilitating multi-discipline teams to quality project execution with strong ownership and excellent interpersonal skills.
• High degree of scientific judgement to resolve discrepancies and create CAPAs that both support rationale and mitigate business and quality risk.
• Consistently met deadlines, delivered results and satisfied compliance and business needs.
• Excellent presentation and writing skills.
• Two-time Bayer Gold recognition award winner for outstanding performance in 2014. From June 2013 to Present (2 years 7 months) Senior Training Scientist @ * Working experience of training in traditional classroom and e-learning
* Trained internal and external customers of diverse professional backgrounds and levels of expertise
*Point of contact for new hire training
* Excellent presentation skills. Certified Dynamic Public Speaker
* Develop and manage software training and certification program content and curriculum
* Focal contact of Company’s Asian pacific customers
* Focal person of training and product support related communications via multichannel of phone, email, chat and web meetings.
* Salesforce savvy
* Knowledge of clinical operations and regulatory affairs From November 2010 to May 2013 (2 years 7 months) Application Specialist @ From 2009 to 2010 (1 year) Postdoctoral fellow @ From October 2007 to December 2008 (1 year 3 months)
PhD, Biochemistry and Biophysics @ University at Buffalo From 2002 to 2007 BS, Medical science @ Fudan University From 1997 to 2002 KongJiang High SchoolProject Management @ UC Berkeley extension Lingjie Guan is skilled in: Biotechnology, Molecular Biology, Quality Assurance, GMP, Pharmaceutical Industry, Lifesciences, Quality System, Genomics, Genetics, Life Sciences, Root Cause Analysis, Corrective Actions, Continuous Improvement, Biochemistry, Drug Discovery
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