**Only candidates local to the New England region of the United States will be considered**
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. Duties include:
- 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.
Azzur Group provides a wide-range of business-to-business professional services and solutions to clients in the pharmaceutical, biotechnology, and medical device industries. We specialize in manufacturing systems, equipment design/installation & startup, commissioning, verification & qualification, all areas of validation, quality assurance, quality control, compliance & audit support, as well as general project/program management.
At Azzur, our greatest strength comes from our people. We have the ability to hire consultants as full time internal employees, providing security and exceptional growth opportunities. They not only have superior technical skills but also adhere to our core values of Putting Others First, Having the Courage to Take Action, Taking Personal Responsibility, and Having fun. Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and clients.
Our Vision: To be the premier choice of clients and talent across our services and products.
Our Mission: To lead the healthcare and life science industries in innovative quality and compliance solutions from Discovery to DeliveryTM.
Location/Region: Waltham, MA (US)