Quality Control Manager – Sterile Pharma (Equity + Unlimited PTO)

hims & hers

Mesa (AZ)

On-site

USD 85,000 - 120,000

Full time

14 days+
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Benefits offered by this job

Competitive salary & equity
Unlimited PTO
Comprehensive benefits

Job summary

Hims & Hers seeks an experienced QC Manager to oversee sterile compounding testing, documentation, and release of CSPs. You will ensure compliance with USP standards and state regulations while leading a QA/QC team across multiple shifts in a fast-paced environment.

You will collaborate with Microbiology, Pharmacist in Charge, and QA to drive CAPA, investigations, and continuous improvement, ensuring data integrity and audit readiness in a dynamic healthcare setting.

Qualifications

  • Bachelor’s degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences or related field.
  • Minimum 3–5 years of QC experience in sterile compounding, pharmaceutical, or biotech environment.
  • Strong knowledge of USP <795>, <797>, <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.

Responsibilities

  • Oversee sampling, testing, and documentation of sterile drug products for sterility, endotoxin, potency, identity, particulate matter, and pH, as applicable.
  • Coordinate 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.
  • Quality control shop floor activities during compounding operations across all shifts.
  • Provide guidance on gowning, line clearance, and visual inspection competency assessments and qualifications.

Skills

Quality control
GMP
Documentation
Regulatory compliance
Team leadership

Education

Bachelor’s degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences

Tools

LIMS
pH meters
Incubators

Job description

Hims & Hers seeks an experienced QC Manager to oversee sterile compounding testing, documentation, and release of CSPs. You will ensure compliance with USP standards and state regulations while leading a QA/QC team across multiple shifts in a fast-paced environment.

You will collaborate with Microbiology, Pharmacist in Charge, and QA to drive CAPA, investigations, and continuous improvement, ensuring data integrity and audit readiness in a dynamic healthcare setting.

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