Quality Assurance Investigations Specialist

Hims & Hers•New Albany, OH

12d•Onsite

About The Position

Hims & Hers is seeking an experienced Quality Assurance Investigations Specialist for the Quality Unit at its 503A compounding pharmacy in New Albany, Ohio. The specialist will lead and support investigations into quality-related events, including deviations, nonconformances, complaints, out-of-specification results, and other events. The role partners with Quality Control and Quality Systems to conduct rigorous root cause analysis, ensure complete documentation, and meet applicable regulatory requirements, including USP <795>, <797>, and <800>. The position reports to the Quality Assurance Manager. The specialist also supports corrective and preventive actions, inspection-ready recordkeeping, cross-functional investigation work, trend analysis, training, and continuous improvement of site procedures. The role is full-time and on-site.

Requirements

Bachelor's degree preferred in a relevant discipline such as science, quality, or an engineering-related field, or an equivalent combination of education and experience.
Three or more years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree.
Pharmacy Technician or trainee license, or willingness to obtain one.
Strong understanding of USP <795>, <797>, and <800>, FDA 21 CFR Parts 210 and 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.
Ability to wear required PPE while working with Hazardous Drugs, including gloves, respiratory protection, and a gown.
Medical approval to wear respiratory protection, including negative- or positive-pressure respirators.
Ability to meet the physical demands of the role, including walking, standing, squatting, bending, and lifting up to 50 pounds.
Willingness to confirm understanding of the potential reproductive, teratogenic, and carcinogenic risks of handling hazardous drugs.

Nice To Haves

GDP and GLP experience.
Proficiency with electronic quality systems such as TrackWise or MasterControl.

Responsibilities

Lead, document, and coordinate investigations of deviations, nonconformances, complaints, out-of-specification results, and other quality events.
Investigate customer complaints and quality-related events in partnership with pharmacists to assess product quality events.
Conduct structured root cause analyses to determine the underlying causes of events.
Ensure investigations are initiated, progressed, and closed on time within defined quality-system timelines.
Collaborate with production, the QC laboratory, and QA to gather evidence and assess event impact.
Identify and recommend practical, risk-based corrective and preventive actions aligned with regulatory and company standards.
Track CAPA implementation and verify effectiveness.
Prepare clear, accurate, compliant investigation reports in accordance with internal SOPs and regulatory requirements.
Maintain complete records to support regulatory inspections and internal audits.
Escalate critical issues to Quality leadership promptly.
Work with QA, QC, and Quality Systems to ensure consistent application of investigation procedures.
Facilitate communication among operations, technical teams, and quality groups during investigations.
Participate in site-level quality review boards and investigation review committees.
Identify investigation trends and recommend systemic improvements.
Support staff training on deviation reporting, investigation practices, and documentation standards.
Contribute to improving site procedures for deviation and OOS management.