Quality Assurance Specialist

Quality Assurance San Francisco, California


Description

We at Azzur Group are looking for an experienced Quality Assurance Specialist to immediately join our Azzur Group: San Francisco Division. The Quality Assurance Specialist role is a FTE project based role.

Responsibilities: 

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 Specialist 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 Preventative 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

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  

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
Azzur Group partners with leading pharmaceutical, biotechnology, and medical device manufacturers to provide efficient and innovative solutions that help them start, scale, and sustain their GxP organizations. With experts at more than 15 locations throughout the United States we take pride in our development and execution of phase-appropriate quality and compliance services to our clients From Discovery To DeliveryTM. 

Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages 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. 

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