QA Specialist

We at Azzur Group are looking for an experienced QA specialist 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: 

• Possesses strong organizational, multitasking, and Technical Writing abilities, with a solid background in manufacturing processes and controls.
• Critically reviews, writes or revises various types of documentation to ensure completeness, accuracy, and compliance including but not limited to manufacturing records for batch and material release, specifications, validation protocols and summary reports, regulatory submissions, product complaints, annual product reviews, Quality Agreements, Supplier Notifications, SOPs, master plans, deviation investigations, CAPAs and change controls.
• Assist and provide guidance on any nonconformance, deviation, or excursion that may occur, experience with deviations and CAPAs required.
• Experience with Trackwise and MasterControl preferred.
• Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations, and standards.
• Conduct risk assessments and provide a commissioning timeline of activities to identify and evaluate and prioritize risks associated with commissioning and qualifying.
• Ability to work well independently and with minimum supervision and identify problematic deviations upfront.
• Be able to help lead team in defining project strategies, developing goals, and ensures project scope is defined and controlled and requests outside the scope are identified within area of expertise.
• Be able to clearly communicate on expertise to internal and external teams when needed.
• Some travel may be required.

Experience: 

• Minimum 2 years previous experience with quality projects within the biotechnology and pharmaceutical industries.
• Batch review and product releases (including batch records, QC documents).
• Deviation and OOS Investigations initiation and completion.
• QA Review of Deviation, OOS, CAPA, and validation protocols/reports documentation.
• Creation of Work Instructions and Procedure.
• Performance of Risk analysis.
• Data integrity assessments and review of client data.

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.

Benefits:

Full Time Employment with Azzur can offer you:
• Flexible PTO
• 401(k) match
• Bonus Eligibility
• Medical Benefits
• Paid Holidays
• Company provided laptop

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 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!