Quality Assurance (QA) Specialists support efforts and deliverables related to systems and processes to establish and ensure compliance. This involves all regulated systems through their life cycle including planning, requirements, specification, design, test, install and verification.
Essential Duties and Responsibilities:
- Prepare and review SOPs and other documents for compliance and provide guidance and counsel to staff as needed.
- Evaluate processes, propose solutions resolve issues and communicate results to support project/task completion.
- Develop and complete deliverables related to QA activities as needed to ensure objectives are met.
- College degree in technical discipline or equivalent work experience and minimum of three years of QA experience in an FDA related regulatory environment is needed.
- Strong organization, communication and interpersonal skills to effectively work in a fast-paced team-based environment.
- In-depth understanding of 21CFR Part 11 and other FDA regulations/guidance for clinical software.
- Proficiency using computer software and systems related to performing QA activities.
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, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:
Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!