Sterile QC Manager: Lead Compliance & Quality

Femtech Insider Ltd.; Mesa (AZ); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO and company holidays

Health benefits including medical, etc

ESPP

401k with employer matching

Job summary

Hims & Hers is seeking a QC Manager to oversee all QC shop floor activities for compounded sterile preparations, ensuring USP guidelines, state boards, FDA guidance.

The role collaborates with Pharmacist in Charge, QA, Microbiology, and Pharmacy leadership; schedule Monday-Thursday 7am-5:30pm; provides leadership, training, and CAPA to improve sterility and quality. Applicants should have a BSc and 3–5 years in QC within sterile environments.

Qualifications

• 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>, <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.
• 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.
• 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.
• Maintain accurate quality records, logs, test results, and retain sample documentation.

Skills

Quality control experience

Sterile compounding

USP 795/797/800

cGMP

Documentation

Data interpretation

Education

BSc in Chemistry/Microbiology/Pharma

Tools

LIMS

Job description

Hims & Hers is seeking a QC Manager to oversee all QC shop floor activities for compounded sterile preparations, ensuring USP guidelines, state boards, FDA guidance.

The role collaborates with Pharmacist in Charge, QA, Microbiology, and Pharmacy leadership; schedule Monday-Thursday 7am-5:30pm; provides leadership, training, and CAPA to improve sterility and quality. Applicants should have a BSc and 3–5 years in QC within sterile environments.