QC Method Validation Engineer

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values.

Essential Duties and Responsibilities:

• Validation of quality control instruments (spectrometers) including the following:

• Review of turnover packages (TOPs) and applicable work instructions
• Review and update User Requirements Specifications (URS) and generate system design and configuration specifications
• Review and update instrument operations and maintenance Standard Operating Procedures (SOPs)
• Manage/support vendor instrument IOQ process and develop/execute appropriate PQ protocols
• Author PQ final reports including trace matrices and data integrity assessments
• Develop and execute test method transfers/validation/verification protocols for the following analytical techniques:
• Raman spectrometer (real-time raw material analysis, FT-NIR spectroscopy (rapid content uniformity testing)
• Develop Transfer/Validation/Verification protocols for QC Analytical Methods
• Develop method SOPs for multiple materials
• Demonstrated method troubleshooting capability
• Knowledge, skills, and expertise in performing chemical experiments that involve the use of liquids, or "wet" chemicals
• Preparing chemical solutions, conducting chemical reactions, and analyzing chemical compounds using various wet chemical techniques such as titrations, extractions, filtrations, and precipitation.

Requirements

• Bachelor's Degree or superior
• 5 years of manufacturing, quality or engineering in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
• Strong understanding of the underlying principles of chemistry, as well as knowledge of laboratory safety and best practices
•   Strong experience with ICH Q2 method qualification/validation requirements, USP, EP, and JP Pharmacopeia
• Hands-on analytical instrumentation experience is preferred.
• Hands-on analytical raw materials experience is preferred.
• Knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, and experience with a wide range of analytical techniques.
• Strong verbal and written communication skills

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.