Quality Systems Specialist

Who you are

You have a strong background in quality systems and compliance, ideally with experience in the healthcare or pharmaceutical industry. Your attention to detail ensures that all compounded products meet company and regulatory standards before release. You are familiar with Good Documentation Practices (GDP) and understand the importance of safeguarding patient safety. You thrive in a collaborative environment and are eager to support the Quality Systems Manager in daily operations. Your ability to manage batch record issuance and perform detailed reviews of executed batch records is crucial to your success in this role.

Desirable

Experience with USP standards and internal SOPs is a plus. You are proactive in identifying areas for improvement and are committed to maintaining high-quality standards in all aspects of your work. You understand the significance of documentation in the quality assurance process and are skilled in filing and escalating events as necessary. Your strong communication skills enable you to work effectively with cross-functional teams, ensuring that quality standards are upheld throughout the organization.

What you'll do

As a Quality Systems Specialist, you will manage the issuance of batch records for compounded lots, ensuring that all documentation is accurate and compliant with regulatory standards. You will perform detailed reviews of executed batch records, identifying any discrepancies and addressing them promptly. Your role will involve collaborating with the Quality Systems Manager to support daily operations and maintain compliance with USP standards and internal SOPs. You will be responsible for filing and escalating events as needed, ensuring that patient safety is always prioritized. Your attention to detail will be essential in maintaining the integrity of the quality assurance process, and you will play a key role in ensuring that all products meet the highest standards before release.

What we offer

Hims & Hers provides a supportive work environment that values collaboration and innovation. You will have the opportunity to contribute to a mission-driven company that is redefining healthcare and making better health outcomes easier to achieve. We offer competitive benefits and a flexible work approach, allowing you to thrive both personally and professionally. Join us in our mission to help the world feel great through the power of better health.