QC Method Validation Engineer

Azzur’s Objective with this Positions:

Azzur is currently designing a team of QC analysts to execute the essential duties and responsibilities listed in the next section. We are working with our clients who have been continuing to outsource more and more of their analytical method development and transfer work. Ideally, our team will consist of individuals that, when working together, can fulfill all the technical experience listed. If you have one or more of these please consider joining our team in this growing service, we are offering to our customers.

Essential Duties and Responsibilities:

• Plan, prioritize, execute, and implement analytical assays
• Wet Chem experience necessary.
• Support QC method technical transfers
• Develop validation protocols for QC analytical instruments
• Develop test/compendial method validation protocols for one or more of the following tests:
  • Thermo Scientific Antaris II FT-NIR, with TQ Analyst and RESULT software
  • Eppendorf Vacufuge™ concentrator, or equivalent
  • Near Infrared Spectroscopy, (TruScanTM Raman Analyzer)
  • Raman Spectroscopy, (Thermo Nicolet iS10 FT-IR with computer installed with OMNIC software)
  • SDS-PAGE
  • HPLC Methodology/Assays for large molecule (proteins)
  • Protein/Bio-Assays ELISA and other related assays
  • UV Spectrophotometry (Protein Concentration)
• Mammalian / Human cell culture experience including:
  • Cell count and culture maintenance
  • Automated Cell Counting (LUNA Cell Counter)
  • Metabolite Analysis (BioProfile FLEX Instrument)
  • Cellular Morphology and Viability
• Demonstrated method troubleshooting capability
• Knowledge, skills, and expertise in performing chemical experiments that involve the use of liquids, or "wet" chemicals
• Raw Materials: techniques such as wet chemistry compendia testing, Raman, NIR, titration assays, gas testing
• Preparing chemical solutions, conducting chemical reactions, and analyzing chemical compounds using various wet chemical techniques such as titrations, extractions, filtrations, and precipitation

 Qualifications:

• Bachelor's Degree or superior
• 2-5 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
• Familiar with ICH Q2 method qualification/validation requirements
• Familiar with the USP, EP, and JP Pharmacopeia
• Hands on analytical instrumentation 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

About Azzur

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.

No matter where you are in the product development lifecycle, Azzur is here to help you start, scale, and sustain your business. From pre-clinical manufacturing to process design and process performance qualification, Azzur Group works hand-in-hand with the world's most renowned manufactures to employ risk-based and phase appropriate GxP solutions.

With a national network of engineers and consultants, we offer comprehensive quality assurance and regulatory compliance, and validation services specifically geared for the complexities of life science.

Do What You Love

We are seeking highly motivated individuals that have the desire to learn, are able to adapt to the ever-changing life sciences field and are flexible to work on various projects throughout the Southern California region all while exuding Azzur’s core values: Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

We aim to serve our clients, create a healthy and fun work environment, and assist with professional growth for each individual through customized career development plans. As a consultant working on multiple cross functional projects, you will be able to quickly garner a wide range of skills and areas of expertise that will propel your career progression.

If a clear career path forward and a positive, transparent, and fun company culture are something you are looking for in your next role, Azzur is the place for you!

Ideal Qualities

Ideal candidates will exhibit, or have the willingness to develop, the following qualities:

• Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
• Willing to work hands on with multiple clients throughout Southern California
• Ensures activities are efficient, optimized, and client-centric
• Highly motivated and organized, solutions-oriented leader
• Curious and adaptable - has the ability to transform knowledge into actionable activities
• Able to produce results in a fast paced, collaborative environment 

  Perks of Working at Azzur

• Medical, Dental and Vision
• Competitive 401K plan
• Flexible Paid Vacation Time
• Employee Recognition Program
• Diversity and Inclusion Initiatives
• Training and Mentorship Opportunities

Learn more about who we are and what makes us great here: https://www.youtube.com/watch?v=9VmKkBLkoFQ

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