Hims AND Hers
Quality Control Manager, Sterile
Gilbert, Arizona · Full-time
Sponsorship not specifiedDetected 8 days ago
Pharmacy PracticeGMPFDA RegulatoryLeadershipCommunicationCollaborationProblem Solving
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.
- Schedule: Monday - Thursday 7am - 5:30pm
- Oversee sampling, testing, and documentation of sterile drug products for sterility, endotoxin, potency, identity, particulate matter, and pH, as applicable.
Responsibilities
- Manage coordination with third-party analytical laboratories, including sample submission, data review, and investigation of test abnormalities.
- 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
- Maintain accurate quality records, logs, test results, and retain sample documentation.
- Support revision and creation of SOPs and work instructions related to QC operations.
- Partner with the Pharmacist in Charge and QA to support audits, mock inspections, and regulatory inspections.
- 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.
Requirements
- Ensure the quality control team remains compliant with gowning, line clearance, and visual inspection competency assessments and qualifications, along with other required training.
- Must be able to lift up to 50lbs.
Nice to have
- Experience working directly in a 503A compounding pharmacy or 503B outsourcing facility.
- Familiarity with FDA guidance on sterile compounding.
- Experience with LIMS or electronic quality systems.
- 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
- Conditions of Employment:
Compensation
- Competitive salary & equity compensation for full-time roles
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
- 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).
- We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging.
- Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability.
Equal opportunity
- 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.
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