Qa Engineer • Mid-Level

Who you are

You have a strong background in quality assurance and investigations, with experience in leading and supporting investigations into quality-related events. You understand the importance of thorough root cause analysis and documentation, ensuring compliance with regulatory requirements such as USP <795>, <797>, <800>, and FDA 503B guidance. Your attention to detail and analytical skills enable you to identify deviations and nonconformances effectively. You are familiar with cGMP standards and have a commitment to maintaining high-quality standards in healthcare operations.

You thrive in collaborative environments, working closely with Quality Assurance (QA), Quality Control (QC), and Quality Systems teams. Your ability to communicate effectively with cross-functional teams ensures that investigations are conducted smoothly and efficiently. You are proactive in identifying potential quality issues and are dedicated to implementing solutions that enhance operational excellence.

You possess a problem-solving mindset, allowing you to navigate complex quality events and develop actionable plans for resolution. Your experience in the healthcare or pharmaceutical industry equips you with the knowledge necessary to understand the unique challenges faced in compounding pharmacy operations. You are committed to continuous improvement and are always looking for ways to enhance quality processes.

Desirable

Experience with regulatory compliance in pharmacy operations is a plus. Familiarity with quality management systems and tools will help you excel in this role. A background in healthcare or a related field will provide you with the context needed to understand the impact of quality assurance on patient outcomes.

What you'll do

As a QA Investigations Specialist at Hims & Hers, you will lead investigations into quality-related events within both 503A and 503B compounding pharmacy operations. Your primary responsibility will be to ensure that thorough root cause analysis is conducted for deviations, nonconformances, and out-of-specification (OOS) results. You will collaborate with QA, QC, and Quality Systems teams to document findings and implement corrective actions.

You will be responsible for ensuring compliance with applicable regulatory requirements, including USP <795>, <797>, <800>, and FDA 503B guidance. Your role will involve conducting investigations in a timely manner, ensuring that all quality events are addressed promptly and effectively. You will also be tasked with maintaining accurate documentation of investigations and resolutions, contributing to the overall quality management system.

In addition to leading investigations, you will participate in quality audits and assessments, providing insights and recommendations for improvement. Your expertise will be valuable in training and mentoring team members on quality assurance practices and regulatory compliance. You will play a key role in fostering a culture of quality within the organization, promoting awareness and understanding of quality standards among staff.

What we offer

Hims & Hers offers a supportive work environment that values quality and innovation in healthcare. You will have the opportunity to work with a team dedicated to improving health outcomes for customers. The company provides competitive benefits and a flexible work approach, allowing you to balance your professional and personal life effectively. Join us in our mission to redefine healthcare and make a positive impact on the lives of individuals seeking better health solutions.