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hims & hers · 2 days ago

Quality Control Manager, Sterile

Gilbert, Arizona

Full-time

Onsite

Mid, Senior Level

3+ years exp

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 seeking an experienced Quality Control Manager to join our Quality Unit at our large-scale compounding pharmacy, where the role involves overseeing quality control operations, conducting inspections, and ensuring compliance with relevant standards and regulations.

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Responsibilities

Lead and perform in-process and post-production quality checks, including product inspection, testing, and disposition at various stages of the compounding process

Manage day-to-day activities on the production floor to ensure product and raw material compliance

Compile, analyze, and present trending data and quality reports to QA management

Oversee investigations related to non-conformances, deviations, and customer complaints, and drive root cause analysis and corrective actions

Manage the product retain program and ensure timely and compliant inspections

Collaborate with production and pharmacy teams to implement quality improvement initiatives

Maintain oversight of critical equipment verifications (e.g., pH meters, balances) and calibrations

Review and approve compound records, Certificates of Analysis (COAs), and raw material documentation to ensure quality standards are met

Draft, revise, and implement SOPs, protocols, and related documentation in alignment with USP standards and regulatory requirements

Ensure ongoing compliance with USP <795,797, and 800> guidelines for sterile and non-sterile compounding and applicable cGMP practices

Support internal audits and external third-party inspections

Manage relationships with contract laboratories for external product testing

Train and mentor pharmacy and production staff on quality standards, processes, and procedures

Qualification

Quality Control ManagementCGMP StandardsUSP ComplianceEnvironmental MonitoringStatistical Quality ControlTechnical WritingLeadership SkillsMicrosoft Office SuiteRoot Cause AnalysisPharmacy Technician LicenseInterpersonal SkillsCommunication SkillsCross-Functional Collaboration

Required

Strong experience with Environmental monitoring

Must have experience working in a sterile floor environment

3+ years of experience in quality control or quality assurance, ideally in a non-sterile and sterile compounding or pharmaceutical manufacturing environment

Strong working knowledge of USP <795,797, and 800> and applicable cGMP standards and making sure protocols are being followed

Experience in a regulated environment (FDA 21 CFR 210/211 experience a plus)

Proven leadership skills with the ability to coach and develop quality and production personnel

Exceptional interpersonal, verbal, and written communication skills

Strong proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook); MRP system experience preferred

Ability to manage multiple priorities, work independently, and maintain high attention to detail

Strong technical writing skills for SOPs, protocols, and reports

Familiarity with quality metrics, root cause analysis, and statistical quality control methods

Proven ability to build and maintain strong cross-functional partnerships, paired with clear, effective communication across all levels of the organization

Have a Pharmacy Technician license or be willing to obtain one within your first six months of employment (we cover costs and will help you obtain your trainee hours)