Quality Engineer

Location: San Diego, CA
Department: Azzur Consulting LLC

Job Description

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   
 
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 the level of incoming experience.  
  • Support day-to-day responsibilities of Deviation / CAPA management
  • Implement the appropriate Quality Management procedures related to the life cycle of the process and utility equipment. Typical QMS include design control, commissioning & qualification, risk management, change control, quality assurance, asset management and corrective/preventative action (CAPA).
  • Author standard operating procedures for the operation and maintenance of manufacturing equipment as well as support utilities.
  • Develop process equipment procurement specifications and data sheets based on approved design documents.
  • Develop design documents for the process equipment in accordance with Good Engineering Practices.
  • Prepare detailed bid evaluations for procurement of the process equipment and system construction packages.
  • Review vendor equipment drawings and specifications and drive the system integration of the equipment control systems with enterprise level computerized systems.
  • Review and comment on detailed design packages from A&E firms.
  • Create mapping of the critical quality attributes against the process requirements and identify the critical process parameters.
  • Generate system impact assessments and critical component assessments including system boundary maps.
  • Lead multi-functional design reviews, identify gaps to the original design documents and update design documents as required to remediate gaps.
  • Capable of preparing commissioning and qualification documents for process equipment and the associated manufacturing lines.
  • Assist in writing and executing process validation documents.
 
Qualifications  
  • BS in Engineering, Science or equivalent technical degree.
  • 5+ years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
  • Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
  • Experience with leading CAPAs and Deviations
  • Excellent written and verbal communication skills; excellent technical writing skills and writing SOPs.
  • Strong interpersonal skills and the ability to work in a team environment.
  • Ability to work effectively in a fast-paced multitasking environment.
  • Strong working knowledge of FDA and cGMP regulations and documentation practices.
  • Proficient in Microsoft Word, Excel, PowerPoint.
  • Working for multiple clients throughout the region.
 
Learn more about who we are and what makes us great here: https://www.youtube.com/watch?v=9VmKkBLkoFQ
  


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