Quality Engineer

Consulting Los Angeles, California


Description

About Azzur:
Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers, and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.

Do What You Love At Azzur Group, it is our purpose to foster a culture that attracts and enables individuals with unique abilities and passions to reach both their life and career goals. We take crucial steps to ensure that each employee is fulfilled both in and out of the office. In addition to our purpose, we have a set of core values that we live and breathe each day.

Every benefit offered here at Azzur is designed to uphold our 4 core values; Putting Others First, Having the Courage to Take Action, Taking Personal Responsibility and Having Fun. It is our mission to serve our communities, build positive and established relationships, create a healthy and fun work environment, ensure each employee and their families are healthy and thriving, grow each employee professionally with one of our customized training programs and keep a clear and open line of communication. We are an equal opportunity employer and promote diverse culture, ethnicity, gender, and age 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.

If philanthropy, long lasting relationships, 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
  • 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.
  • 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. The QA analyst will be responsible for supporting internal GMP activities for protein purification processes. The candidate is expected to provide guidance for maintaining and enhancing quality and compliance aspects of the Investigation and CAPA programs.
  • Prepare and drive Corrective and Preventive Action (CAPAs) through closure with respective system/department owners
  • Support triage and conduct Root Cause Analysis for investigation(s)
  • Support day-to-day responsibilities of Deviation / CAPA management
  • Provide status reports, including relevant quality metrics/trending and effectiveness monitoring. May participate in the management review process
  • Manage document change control activities. Write and edit controlled documents to ensure documents comply with applicable regulatory and internal requirements
  • Prepare and implementing quality assurance policies and procedures
  • Work in a collaborative manner with stakeholders to ensure all quality and compliance matters are addressed in a satisfactory manner
Qualifications:
  • BS Engineering or related discipline
  • 5+ years’ experience in the pharmaceutical and/or biotechnology industry is required
  • Experience with FDA compliance and cGMP is required
  • Have had experience developing successful Deviation/CAPA Management programs that have led to employee performance improvement and ultimately had a positive influence on the business overall performance and effectiveness.
  • Ability to analyze data and apply statistical techniques.
  • Experience with Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.)
  • Excellent written and verbal communication skills

Perks of Working at Azzur:
  • Medical, Dental and Vision
  • Competitive 401K plan
  • Volunteer Paid Time Off
  • Flexible Paid Vacation Time
  • Employee Recognition Program
  • Diversity and Inclusion Initiatives
  • Training and Mentorship Opportunities
Find us on social media Instagram:
Azzur_LA

View our culture video in YouTube: https://www.youtube.com/watch?v=GPNjmsDu0LY


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