Full-Time

Quality Control Manager

Sterile

hims & hers

hims & hers

1,001-5,000 employees

Telehealth platform for personalized medical treatments

No salary listed

New Albany, OH, USA

In Person

Bachelor's

Category
Biology & Biotech (1)
Required Skills
Microsoft Office
GMP
Word/Pages/Docs
Excel/Numbers/Sheets
Microsoft Outlook
PowerPoint/Keynote/Slides

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Requirements
  • Strong experience with environmental monitoring.
  • Experience working in a sterile floor environment.
  • At least 3 years of experience in quality control or quality assurance in a sterile compounding or pharmaceutical manufacturing environment.
  • Strong working knowledge of United States Pharmacopeia chapters 795, 797, and 800 and applicable current good manufacturing practice standards, including ensuring protocols are followed.
  • Experience in a regulated environment; Food and Drug Administration 21 CFR 210/211 experience is a plus.
  • A Pharmacy Technician license, or willingness to obtain one within the first six months of employment.
  • Proven leadership skills with the ability to coach and develop quality and production personnel.
  • Strong proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.
  • Ability to manage multiple priorities, work independently, and maintain high attention to detail.
  • Strong technical writing skills for standard operating procedures, protocols, and reports.
  • Familiarity with quality metrics, root cause analysis, and statistical quality control methods.
  • Ability to build and maintain strong cross-functional partnerships and communicate effectively across all organizational levels.
  • Ability to work with hazardous drugs while wearing required personal protective equipment.
  • Medical approval to wear negative- or positive-pressure respiratory protection.
  • Ability to perform the stated physical duties, including lifting up to 50 pounds.
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 quality assurance 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, including pH meters and balances, and calibrations.
  • Review and approve compound records, Certificates of Analysis, and raw material documentation to ensure quality standards are met.
  • Draft, revise, and implement standard operating procedures, protocols, and related documentation in alignment with United States Pharmacopeia standards and regulatory requirements.
  • Ensure ongoing compliance with United States Pharmacopeia chapters 795, 797, and 800 guidelines for sterile and non-sterile compounding and applicable current good manufacturing practice standards.
  • 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.
Desired Qualifications
  • Experience working in a 503A or 503B compounding facility.
  • Prior management of environmental monitoring or contamination control programs.
  • Experience supporting facility expansions, Food and Drug Administration inspections, or operational scale-up projects.
  • Material Requirements Planning system experience.
  • Food and Drug Administration 21 CFR 210/211 experience.

Hims & Hers is recognized for blending telehealth convenience with a wide range of personalized medical services, from sexual health to mental health. The employment environment is backed by a commitment to technical excellence and a progressive approach to healthcare, offering opportunities to work on cutting-edge treatments that address diverse patient needs. Its culture promotes innovation and patient-centric solutions, providing a motivating workspace for professionals looking to impact healthcare accessibility and quality.

Company Size

1,001-5,000

Company Stage

Post IPO Equity

Headquarters

San Francisco, California

Founded

2017

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Benefits

Full healthcare - High-coverage medical, dental & vision coverage for individuals and families

Generous PTO

Retirement planning - Take advantage of our 401(k) plan including contribution matching

WFH stipend

Robust compensation

Employee discount

Utility stipend - An extra $75 each month to cover extra cell phone, internet, or data usage

Spending accounts - Options for additional HSA and FSA plans to help toward healthcare costs