Department: Azzur Consulting LLC
We at Azzur Group are looking for an experienced QA Auditor to join our Azzur Consulting: Austin team.
Who we are:
Azzur Group is a professional service company providing biotechnology and pharmaceutical clients with engineering, validation, CSV-IT, technical, quality and consulting services. At Azzur, we look to hire full- time consultants who deliver results to our valued clients while providing you the opportunity to develop and grow in the industry through diverse project assignments.
Essential Duties and Responsibilities:
- Manage Client Auditing Process:
- Act as the Project Coordinator for audits including contacting sites, scheduling, and responding to client requests
- Audit Responsibilities include:
- GLP, GCP, GMP Audits
- Audit preparation and agenda
- Audit conduct (on-site and remote)
- Audit reports.
- Review of CAPA action plans
- Initial, Routine, and For cause Audits
- Report all project details to the Director of Quality Services (document status, document delivery, scheduling)
- This position may include supplier management, supplier risk assessments, training, and other auditing-related responsibilities.
- Note that this position is expected to have 60-70% travel, including conducting at least three on-site audits a month. Remote work is expected for audit preparation and reporting, and virtual audits.
- May be asked to perform client work as a QA Consultant.
- Bachelor’s Degree with a study concentration in a scientific discipline, preferably the biopharma/med device industry.
- 3 years experience with Quality Systems in Pharmaceutical, Biopharmaceutical and/or Medical Device
- 3-5 yr experience as a technical contributor and/or auditing
- 5 years experience with GLP and GMP Manufacturing in the Pharmaceutical and/or Medical Device industry
- Customer service experience is highly preferred
- GCP Clinical Site and CRO Auditing Experience
- GTP and gene therapy experience
- Knowledge of Regulations and Standards related to auditing
- Computer skills, basic mathematical skills, use of spreadsheets
- Customer service/client relations
- Communication proficiency
- Attention to detail
- Can work productively independently with minor supervision
- Self-motivated, flexible, dependable, and available
- Excellent organizational and time management skills
- Excellent word processing and computerized system skills
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.
Full Time Employment with Azzur can offer you:
• Flexible PTO
• 401(k) match
• Bonus Eligibility
• Medical Benefits
• Paid Holidays
• Company provided laptop
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 5 core values; Integrity, 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.
Using our 4 Core Values as guidance, we expect all Azzur Employees to:
• Put Others First,
• Have the Courage to Take Action,
• Take Personal Responsibility, and
• Have Fun!