Department: Azzur of CA, LLC
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
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 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
- 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
- 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
View our culture video in YouTube: https://www.youtube.com/watch?v=GPNjmsDu0LY