hims & hers · 8 hours ago
Quality Control Manager, Sterile
Gilbert, AZ
Full-time
Onsite
Mid, Senior Level
3+ years expHims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. The Quality Control Manager is responsible for overseeing and executing all QC shop floor activities to ensure compounded sterile preparations meet established quality, safety, and regulatory standards.
Health CareLifestyleMen'sWellnessWomen's
Responsibilities
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
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
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
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
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
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
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
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
Qualification
Required
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 , USP , USP , 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
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
Benefits
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
Company
hims & hers
Hims is a wellness brand that helps men and women get access to products for skin care, hair loss, and sexual health.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.23BKey Investors
Franklin TempletonIVPThrive Capital
2025-05-08Post Ipo Debt· $1B
2021-01-21Post Ipo Equity· $75M
2021-01-21IPO
Leadership Team
Andrew Dudum
Founder & CEO
Yemi Okupe
CFO
Recent News
dcm.com
2025-12-31
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