Quality Assurance Investigations Specialist

The role

You will lead and support investigations into quality-related events within a 503A compounding pharmacy. You will perform root cause analysis and manage corrective and preventive actions to ensure regulatory compliance.

What you will do

• Lead, document, and coordinate investigations of deviations, nonconformances, complaints, OOS results, and other quality events.
• Investigate customer complaints and quality-related events with pharmacists.
• Perform structured root cause analyses.
• Ensure timely initiation, progress, and closure of investigations.
• Collaborate with production, QC laboratory, and QA to gather evidence.
• Identify and recommend appropriate CAPAs.
• Track CAPA implementation and verify effectiveness.
• Prepare clear, accurate, and compliant investigation reports.
• Maintain complete records to support regulatory inspections and internal audits.
• Identify trends across investigations and recommend systemic improvements.

Required qualifications

• Pharmacy Technician or trainee license, or willingness to obtain one.
• Strong understanding of USP <795>, <797>, and <800> standards, FDA 21 CFR Parts 210 & 211, and cGMP.
• Experience with investigations, deviation management, and escalation procedures.
• Excellent attention to detail, documentation practices, and organizational skills.
• Excellent written and verbal communication skills, including technical writing.
• Strong collaboration skills across multidisciplinary teams.
• Ability to manage multiple investigations under tight timelines.
• Proficiency in Google Workspace.
• Must be able to lift up to 50lbs.
• Physical exertion required including 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 ho

Nice to have

• Bachelor's degree preferred in a relevant discipline (science, quality, or engineering-related field), or an equivalent combination of education and experience.
• 3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree.
• GDP and GLP experience preferred.
• Proficiency with electronic quality systems (e.g., TrackWise, MasterControl) preferred.

Benefits

• Competitive salary & equity compensation
• Unlimited PTO
• Company holidays
• Quarterly mental health days
• Comprehensive health benefits, including medical, dental & vision
• Parental leave
• Employee Stock Purchase Program (ESPP)
• 401(k) with employer matching contribution
• Offsite team retreats

Before you apply

• Requires working with Hazardous Drugs (HD) and wearing Personal Protective Equipment (PPE).
• Requires medical approval to wear respiratory protection.
• Must be willing to confirm understanding of potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.

About the company

Hims & Hers is a health and wellness platform that provides access to personalized, affordable healthcare. It is a public company traded on the NYSE.