Quality and Compliance Specialist

Job Description

Company Information At Advarra, we are passionate about making a difference in the world of clinical research and advancing human health. With a rich history rooted in ethical review services combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A market leader and pioneer, Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials. Company Culture Our employees are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives. At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each employee is not only valued but empowered to thrive and make a meaningful impact. Job Duties & Responsibilities Data Mining, Analysis & Reporting: Collect and analyze operational data to identify trends, root causes of issues, and opportunities for improvement. Derive reports and gather data pertaining to quality and share with respective heads and leads on an ongoing basis. Process Writing and Improvement: Collaborate with teams to understand requirements, help with documentation, implementation, and optimization of processes, ensuring they meet quality and efficiency targets. Auditing & Compliance: Assist in conducting regular audits of operational processes to ensure compliance with internal and external quality standards. Collaborate with respective teams in addressing identified quality incidents and issues. Performance Monitoring: Track and report on Key Performance Indicators (KPIs) related to quality and operational efficiency. Issue Resolution: Provide inputs (where possible) to assist in timely completion of the CAPA (Corrective and Preventive Actions) log for all significant non-conformities. Documentation: Maintain up-to-date records of customer environment access log, training details for institution specific guidelines and any other tracker/log and ensure the latest information is available at any time point. Process Documentation: Provide inputs and assist in reviewing SOP’s, QWI’s, QSP’s and other guidance documents for the India Operations team. Collaboration: Work closely with the service teams to drive quality initiatives and ensure customer satisfaction. Risk Management: Understand the risk management process, provide periodic input, and assist in training the team on the requirements. Training: Assist in training staff in quality standards, new processes, and improvement initiatives. Other tasks: Perform all other duties as required, while establishing new services within the India Operations team, and as assigned. This role is open to candidates working hybrid in Bengaluru, Karnataka, India. Basic Qualifications Master’s degree in Life Sciences. 2-4 years of experience in quality assurance, operations, or a similar role. Proficiency with MS Office (Word, Excel, and PowerPoint) Familiarity with quality management systems (QMS) and methodologies like Six Sigma, Lean, or ISO 27001 standards. Problem-solving mindset with attention to detail. Strong communication and collaboration skills to work with cross-functional teams. Effective communication skills, including listening, writing, and speaking. Preferred Qualifications Strong time management skills and ability to effectively manage multiple priorities. Strong analytical, problem-solving, and interpersonal skills Ability to work independently and integrate into a team environment. Physical And Mental Requirements Sit or stand for extended periods of time at stationary workstation Regularly carry, raise, and lower objects of up to 10 Lbs. Learn and comprehend basic instructions Focus and attention to tasks and responsibilities Verbal communication; listening and understanding, responding, and speaking EEO Policy Advarra is an equal opportunity employer that is committed to diversity, equity and inclusion and providing a workplace that is free from discrimination and harassment of any kind based on race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions, sexual orientation, and gender identity), national origin, age, disability or genetic information or any other status or characteristic protected by central, state, or local law. Advarra provides equal employment opportunity to all individuals regardless of these protected characteristics. Further, Advarra takes affirmative action to ensure that applicants and employees are treated without regard to any of these protected characteristics in all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and separation from employment. Show more Show less