QA/Analytical Method Validation Specialist

Location: Foster City, CA
Date Posted: 10-23-2017
Title: QA/Analytical Method Validation Specialist
Type of role: Contract 6+ months
Location: Foster City, CA

***Cadidate must have a Green Card or US Citizenship

• 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.
• Proficiency in small molecules and solid oral dosage forms is preferred.
• 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.
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.
• 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.
• Bachelor’s degree in chemistry, microbiology, or related scientific field.
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