QA Compliance Specialist

A QA Compliance Specialist at Advanced Accelerator Applications is responsible for implementing and managing quality systems at the Indianapolis site. This includes leading the Quality Management Review program, participating in inspections, and facilitating training on compliance programs. The specialist ensures the adherence to both Novartis standards and regulatory requirements, significantly contributing to the oversight and improvement of QA initiatives.

To qualify as a QA Compliance Specialist at Advanced Accelerator Applications, candidates must possess a B.S. degree in a relevant field, such as Life Sciences or chemistry, along with six years of experience in a GMP biopharmaceutical environment. Notably, at least two years of experience in a Quality Assurance role is essential, specifically focusing on Data Integrity compliance. Candidates should also be familiar with cGMP regulations and possess strong communication and technical writing skills.

A QA Compliance Specialist at Advanced Accelerator Applications will undergo comprehensive training that covers quality systems, compliance programs, and regulatory requirements pertinent to the biopharmaceutical industry. This training will also include elements on facilitating effective self-inspections and preparing for corporate and global health authority inspections, empowering them to support the execution of high operational standards.

The QA Compliance Specialist plays a vital role in enhancing quality assurance at Advanced Accelerator Applications by actively overseeing the implementation of quality management systems. They are responsible for monitoring key performance indicators, facilitating necessary training, and representing QA compliance on various project teams, all of which collectively improve the efficiency and compliance of operational practices.

Desirable requirements for a QA Compliance Specialist at Advanced Accelerator Applications include experience with radiopharmaceutical therapies and a history of performing QA compliance tasks such as conducting self-inspections. Familiarity with the specifics of industry regulations like cGMP, as well as prior experience in authoring or reviewing standard operating procedures, can give candidates an edge in this position.

In answering this question, emphasize your previous roles that involved working in a GMP environment. Describe specific responsibilities you had regarding quality assurance, any systems you were part of developing or maintaining, and how your efforts contributed to overall compliance in your previous companies.

Data Integrity refers to maintaining and assuring the accuracy and consistency of data over its lifecycle. In the context of QA Compliance, it is crucial because regulatory agencies expect that all data submitted for evaluation are truthful, reliable, and follow compliance standards—a vital aspect of the pharmaceutical world that affects patient safety.

Discuss the systematic steps you take to prepare for a Quality Management Review, including gathering relevant data, reviewing KPIs, and consulting team members. Outline how you ensure thoroughness, engage stakeholders, and recommend actionable changes based on the findings from your review.

Share your proactive approach to inspections, which may involve conducting self-inspections, training staff on inspection protocol, and preparing documentation that demonstrates compliance with regulations. Highlight your ability to communicate with regulatory agencies effectively throughout the process.

Explain your method for identifying high-quality risks, the criteria you utilize for assessment, and how you follow the established protocols for escalation. Include examples of past situations where you successfully managed risk and ensured compliance through timely communication.

Emphasize the importance of continuous education in QA Compliance and discuss your experience facilitating training sessions. Explain your training methods, tailoring content to different staff levels, and ensuring that all employees understand their roles in maintaining compliance.

Discuss your commitment to staying informed about industry regulations and changes. Mention specific resources you utilize, such as professional networks or training programs, and provide an example of a time you adapted processes or guidelines in response to a regulatory change.

Share a specific instance where you identified a process inefficiency in quality management and describe the steps you took to improve it. Highlight the outcomes and how they positively impacted compliance and operations.

Talk about your hands-on experience with SOPs including drafting, reviewing, and ensuring adherence to them. Outline how you ensure that SOPs are current, clearly understood by team members, and integrated into daily operations.

Discuss techniques you use to foster a culture of compliance within your team, such as regular communication, recognition of compliance efforts, and encouraging feedback. Provide examples of initiatives that led to increased engagement in quality assurance practices.