Compounding Operations Deviation / CAPA Specialist

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 discounts on hims & hers & Apostrophe online products

• 401k benefits with employer matching contribution

• Offsite team retreats

Conditions of Employment: 

• This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.

• This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).

• Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.

• Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [email protected] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.

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