Quality Control Manager, Sterile

Job description

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about http://hims.com/about and hims.com/how-it-works http://hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals http://www.hims.com/careers-professionals. About the Role: The Quality Control (QC) Manager is responsible for overseeing and executing all QC shop floor activities to ensure compounded sterile preparations (CSPs) meet established quality, safety, and regulatory standards. This role ensures compliance with USP <795>, USP <797>, USP <800>, state board requirements, and FDA guidance applicable to 503A sterile compounding environments. The QC Manager works closely with the Pharmacist in Charge, Quality Assurance, Microbiology, Compounding Operations, and Pharmacy leadership to maintain a robust quality control program that protects patient safety and supports continuous improvement. Schedule: Monday - Thursday 7am - 5:30pm You Will: PRODUCT TESTING & RELEASE - Oversee sampling, testing, and documentation of sterile drug products for sterility, endotoxin, potency, identity, particulate matter, and pH, as applicable. - Manage coordination with third-party analytical laboratories, including sample submission, data review, and investigation of test abnormalities. - Review and approve Certificates of Analysis (COAs) and ensure results meet specifications prior to product release. ENVIRONMENTAL & PROCESS MONITORING - Manage quality control shop floor activities during compounding operations to ensure appropriate coverage over all shifts. - Ensure the quality control team remains compliant with gowning, line clearance, and visual inspection competency assessments and qualifications, along with other required training. - Provide guidance to quality control team on room clearance, line clearance and Acceptable Quality Level (AQL) inspections - In collaboration with Microbiology, supervise viable and non-viable environmental monitoring in ISO-classified areas in accordance with USP <797>. - Oversee personnel monitoring (gloves, gowns, fingertip sampling) and ensure compliance with established frequency and limits. - Trend environmental monitoring data and implement corrective actions for excursions. DEVIATION, OOS, AND INVESTIGATION MANAGEMENT - Collaborate with Microbiology and Pharmacist in Charge on investigations for out-of-specification (OOS) results, sterility failures, and environmental excursions - Conduct and document event investigations and root-cause analyses; propose and verify effectiveness of corrective and preventive actions (CAPA). - Ensure investigations are timely, compliant, and thorough prior to seeking pharmacist approval DOCUMENTATION & RECORD CONTROL - Ensure quality batch record review checklists are completed in accordance with internal processes and procedures. - Maintain accurate quality records, logs, test results, and retain sample documentation. - Ensure data integrity principles (ALCOA+) are followed across all QC-related records. - Support revision and creation of SOPs and work instructions related to QC operations. EQUIPMENT OVERSIGHT - Collaborate with the microbiology manager on qualification, calibration, and maintenance of QC instruments (e.g., particle counters, incubators, pH meters, balances). - Ensure appropriate compounding equipment logs, preventive maintenance, cleaning and calibration files are maintained and up-to-date. QUALITY SYSTEMS SUPPORT - Partner with the Pharmacist in Charge and QA to support audits, mock inspections, and regulatory inspections. - Participate in risk assessments, change controls, and continuous improvement meetings. - Support training of pharmacy staff on quality compliance requirements and aseptic principles. OPERATIONAL SUPPORT - Provide technical and shop floor support to sterile compounding personnel related to testing requirements, sampling, and product specifications. - Ensure proper handling, storage, and disposal of testing materials, media, and reagents. - Monitor trends to identify opportunities to enhance sterility assurance and product quality. You Have: - Bachelor’s degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or related field. - Minimum 3–5 years of QC experience in a sterile compounding, pharmaceutical, or biotech environment. - Strong knowledge of USP <795>, USP <797>, USP <800>, cGMP, and state pharmacy regulations. - Experience with laboratory investigations, root-cause analysis, and CAPA processes. - Demonstrated ability to interpret analytical data and laboratory test results. - Excellent documentation skills and attention to detail. PREFERRED QUALIFICATIONS - Experience working directly in a 503A compounding pharmacy or 503B outsourcing facility. - Familiarity with FDA guidance on sterile compounding. - Supervisory experience or the ability to lead and develop QC staff. - Experience with LIMS or electronic quality systems. CORE COMPETENCIES - Quality-focused decision-making - Strong problem-solving and analytical ability - Aseptic knowledge and high attention to detail - Effective communication and collaboration across pharmacy and quality teams - Ability to manage multiple priorities in a fast-paced, regulated environment OUR BENEFITS (THERE ARE MORE BUT HERE ARE SOME HIGHLIGHTS): - Competitive salary & equity compensation for full-time roles - Unlimited PTO and company holidays - Comprehensive health benefits including medical, dental & vision, and parental leave - Employee Stock Purchase Program (ESPP) - 401k benefits with employer matching contribution Conditions of Employment: - This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required. - This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR). - Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve-hour shift. Must be able to lift up to 50lbs. - Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs. We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match. Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at accommodations@forhims.com and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address. To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement https://www.hims.com/global-candidate-privacy-statement.