Analytical Instrument and Method Validation

Location: Los Angeles, CA
Department: Azzur of CA, LLC

Job Description

Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

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:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

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
  • Understands the competitive landscape of the medical device, pharmaceutical, and biotechnology industry
  • Willing to work hands on, assist with building client libraries, learn from a mentor and become a mentor for others.
  • Understands worldwide regulations and phase appropriate applications
  • Draws insights from projects and supplemental research to help drive new and existing growth.
  • 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

Essential Duties and Responsibilities

Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.

  • Develop, qualify and implement analytical methods to support stability and various formulation development studies
  • Write and review technical documents supporting analytical development and regulatory filings, including analytical method procedures (SOPs) and method development reports
  • Participate in general lab instrument maintenance and perform trouble shooting independently
  • Evaluate, interpret, and present data at group meetings
  • Bring in new ideas from the literature or external practices and propose alternative approaches
  • Maintain accurate and complete laboratory record.
  • Provide training to junior analysts.
  • Collaborate with other team members.

 

Requirements

  • Bachelor's Degree
  • 5-7 years of manufacturing, quality or engineering in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
  • 2-4 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field
  • 1-2 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a Ph.D. in Science/related field
  • Demonstrated experience in Quality Control
  • Good knowledge of analytical method validation
  • Good knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, and experience with a wide range of analytical techniques.
  • Reasoning ability including strong analytical and problem-solving abilities
  • Strong verbal and written communication skills

 



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