A leading US biopharmaceutical organisation with a solid commercial portfolio of life saving drugs within a number of therapy areas have a new QA Specialist III job opportunity at their offices in Foster City, California. The company has a growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents.
- Reviews method validation efforts from phase 1 through commercial and transfer.
- Review existing quality procedure workflows, identifies areas of improvement for efficiency and compliance, and recommends implementation efforts.
- Bachelor's degree in chemistry, microbiology, or related scientific field, and proficiency in Mandarin (Chinese)
- Hands on experience with validation of analytical methods (HPLC, Dissolution, water content, particle size...)
- Proficient in Quality Systems and CGMP standards applicable to clinical and commercial products and AD/QC laboratory operations. Knowledge of European regulations is desirable
- An accountable team player and leader who is detail and quality-oriented with solid understanding of quality assurance principles, systems, methods and procedures.
- Excellent attitude with good verbal, interpersonal communication, excellent judgment and multitasking skills who can adapt to changing priorities.
- Proficiency in small molecules and solid oral dosage forms is preferred.
- Possess critical thinking skills when making sound quality decisions based on risk management and available data.
- Ability to recognize deviations from accepted practice and apply knowledge of current Good Manufacturing Practices (CGMP) on a daily basis.
- Excellent technical writing skills when creating and presenting reports for management.
- Ability to work independently in a high-paced environment with tight timelines, while maintaining accuracy and quality.
- Ability to effectively present data, findings, improvement initiatives/projects to QA and cross-functional leadership.
- Relevant background in Quality Control or Analytical Method Development is highly desired
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Christopher Frank on +1 267 405 6996 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.