Quality Control Specialist (Day Shift)

📋 Description • Hims & Hers, a leading health and wellness platform dedicated to helping individuals feel great through accessible, personalized, and affordable healthcare, is seeking a highly motivated and experienced Quality Control Specialist to join our dynamic Quality Unit in Gilbert, Arizona. This is a critical day shift position, operating from 6:30 am to 5:00 pm, with a schedule of either Sunday through Wednesday or Wednesday through Saturday. As a Quality Control Specialist, you will play a pivotal role in ensuring the highest standards of product quality and regulatory compliance, directly contributing to our mission of redefining healthcare and delivering exceptional customer experiences. • In this role, you will be instrumental in driving continuous improvement initiatives across our manufacturing processes. You will work closely with the Quality Control Manager, providing essential support and reporting on quality-related activities. Your primary responsibility will be the meticulous inspection and testing of products and raw materials before, during, and after manufacturing. This ensures that all products not only meet but exceed company and regulatory standards, including USP, SOPs, and cGMP guidelines where applicable. You will be a key player "on the floor," actively participating in the disposition of materials and upholding stringent Quality Assurance (QA) policies and procedures. • A significant aspect of your role will involve performing in-process and post-production quality checks. This includes conducting various tests and visually assessing products within the compounding suites to guarantee their acceptability. You will also be responsible for performing line clearances, where applicable, to ensure a clean and controlled manufacturing environment. AQLs (Acceptable Quality Limits) will be performed during the visual inspection process, adding another layer of rigorous quality assurance. • You will be tasked with generating comprehensive reports and providing trending data to QA management, offering insights into product quality and process performance. Your support will extend to various departments in reporting, handling, and escalating investigations related to quality deviations or non-conformances. Furthermore, you will actively support external manufacturer non-conformance investigations, identifying root causes and recommending process improvements to enhance overall quality. • Managing product retain samples will be a key responsibility, ensuring proper storage and accessibility for future reference or testing. You will also contribute to the change control system, proposing and implementing improvement solutions that enhance product quality and manufacturing efficiency. Your involvement in quality processes within the pharmacy will be extensive, encompassing inspections, calibration checks of essential equipment like pH meters and scales, and thorough investigations of non-conformances, deviations, and customer complaints. • A crucial part of your day-to-day activities will involve the meticulous documentation and review of critical records. This includes the generation of SOPs (Standard Operating Procedures), the review of batch records to ensure accuracy and completeness, and the acceptance of Certificates of Analysis (COAs). You will also be responsible for reviewing USP monographs to ensure adherence to pharmacopeial standards. • You will proactively identify training needs within the quality unit and provide detailed reports to the QC Manager and Lead Pharmacist, ensuring that all team members are up-to-date with quality standards and best practices. As needed, you will assist with incoming raw material inspections, following established guidelines for collection, testing, and reporting of quality data to ensure the integrity of our starting materials. • Your expertise will be called upon to assist in drafting SOPs and protocols, ensuring they align with internal global policies, USP standards, and other applicable regulatory guidelines. You will play a vital role in ensuring compliance with critical USP chapters, including USP <795> (Non-sterile Compounding), USP <797> (Sterile Compounding), USP <800> (Hazardous Drugs – Handling in Healthcare Settings), and cGMP cleaning standards. • You will also assist in audit activities, supporting both third-party and internal audits as required to maintain compliance and identify areas for improvement. This includes managing samples sent to contract laboratories for specialized testing, ensuring timely and accurate analysis. • This role demands a proactive, detail-oriented individual who thrives in a fast-paced, regulated environment. You will be a key contributor to Hims & Hers' commitment to delivering safe, effective, and high-quality health and wellness products to our customers.