Specialist, Compounding Operations Deviation / CAPA

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. 

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.

​​About the Role:

The Compounding Operations Deviation / Root Cause Specialist is responsible for investigating deviations within the compounding area, identifying root causes, and driving effective corrective and preventive actions (CAPAs). This role ensures compliance with current Good Manufacturing Practices (cGMP), supports continuous improvement, and strengthens operational discipline through data-driven problem-solving.

You Will:

Deviation Management & Root Cause Analysis

• Lead or support timely and thorough investigations of production deviations, batch discrepancies, or out-of-specification (OOS) results related to compounding.

• Conduct structured root cause analysis using tools such as 5 Whys, Fishbone Diagrams (Ishikawa), and Fault Tree Analysis.

• Work cross-functionally with QA, Engineering, and Production teams to determine immediate and systemic causes.

• Maintain compliance with USP <795>, <797>, and <800> (as applicable) and other regulatory guidelines.

Corrective and Preventive Actions (CAPA)

• Develop, implement, and verify the effectiveness of CAPAs associated with compounding deviations.

• Track and trend recurring deviation types to proactively address process weaknesses.

• Support the implementation of process or procedural changes to prevent reoccurrence.

Documentation & Compliance

• Ensure all deviation investigations are documented clearly, accurately, and in accordance with regulatory and internal standards.

• Collaborate with document control to revise SOPs or batch records if needed.

• Prepare investigation summaries and contribute to internal and external audit responses.

Operational Support & Continuous Improvement

• Partner with compounding operators and supervisors to identify potential failure points in processes or equipment.

• Participate in kaizen events and quality improvement initiatives focused on compounding performance.

• Maintain awareness of industry best practices and regulatory expectations for deviation handling.

You Have:

• Bachelor’s degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or a related field.

• 3–5 years of experience in a cGMP manufacturing environment, preferably with compounding or formulation experience.

• Strong working knowledge of deviation management and root cause analysis methodologies.

• Familiarity with USP 795 and 800, FDA, EU GMP, and other regulatory agency expectations.

• Experience using quality management systems (e.g., TrackWise, Veeva QMS).

Preferred Skills & Certifications:

• Lean Six Sigma Yellow or Green Belt certification.

• Proficient in technical writing and investigation report preparation.

• Strong analytical, organizational, and interpersonal skills.

• Detail-oriented with the ability to work under pressure and meet tight timelines.

Our Benefits (there are more but here are some highlights):

• Competitive salary & equity compensation for full-time roles

• Unlimited PTO, company holidays, and quarterly mental health days

• Comprehensive health benefits including medical, dental & vision, and parental leave

• Employee Stock Purchase Program (ESPP)

• Employee disco