Quality Control Manager, Sterile

Hims & Hers • Gilbert, AZ

9h

About The Position

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. This role ensures compliance with USP <795>, USP <797>, USP <800>, state board requirements, and FDA guidance applicable to 503A sterile compounding environments. The QC Manager works closely with the Pharmacist in Charge, Quality Assurance, Microbiology, Compounding Operations, and Pharmacy leadership to maintain a robust quality control program that protects patient safety and supports continuous improvement.

Requirements

• 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>, USP <797>, USP <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.

Nice To Haves

• 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.

Responsibilities

• Product Testing & Release
• 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.
• Environmental & Process Monitoring
• 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.
• Deviation, OOS, and Investigation Management
• 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
• Documentation & Record Control
• 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.
• Equipment Oversight
• 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.
• Quality Systems Support
• 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.
• Operational Support
• 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.

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
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level