Quality Control Analyst

Summary

Responsible for assisting with the startup, qualification and operation of the QC laboratory including the development of procedures, raw material and component testing processes, analytical methods transfer and validation, and in-process and finished product release and stability testing.

Essential Duties:

• Perform incoming raw material testing, component inspection, in-process analysis, and finished product release testing.
• Maintain the laboratory in accordance with SOPs, cGMPs, and FDA regulations
• Assist with the development and validation of analytical methods
• Responsible for meeting milestones on multiple projects
• Calibrate, operate and maintain analytical instrumentation for product testing.
• Write and revise Standard Operating Procedures, Specifications and Data Collection Forms.
• Recommend innovative approaches to problem solving.
• Understand and use experimental design where appropriate.
• Other duties as assigned.

Qualifications:

• BS in Chemistry or related field
• 3+ years of experience in a pharmaceutical laboratory
• Experience performing routine and non-routine HPLC analytical tests
• Experience performing wet chemistry assays
• Knowledge of cGMP/GLP regulatory requirements
• Excellent technical writing and organizational skills
• A good working knowledge of Microsoft Office programs
• Qualified to work with controlled substances
• Good interpersonal skills and the ability to work well in a team environment