Quality Assurance Investigations Specialist

Hims & Hers•Mesa, AZ

1d•Onsite

About The Position

Hims & Hers is seeking an experienced Quality Assurance Investigations Specialist to join the Quality Unit at its 503A compounding pharmacy in Gilbert, Arizona. Reporting to the Quality Assurance Manager, the specialist leads and supports investigations into quality-related events, partnering with Quality Control and Quality Systems to ensure deviations, nonconformances, complaints, and other events receive thorough investigation, rigorous root cause analysis, and complete documentation. The role ensures investigations comply with applicable requirements, including USP <795>, <797>, and <800>. The position works Monday through Friday, 8 a.m. to 5 p.m. It involves working with hazardous drugs and wearing required personal protective equipment throughout that work. Medical approval is required to wear respiratory protection, including negative- or positive-pressure respirators. Associates must understand the potential reproductive, teratogenic, and carcinogenic risks associated with handling certain hazardous drugs.

Requirements

Bachelor's degree in a relevant discipline, such as science, quality, or an engineering-related field, or an equivalent combination of education and experience; a degree is preferred.
At least 3 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.
Analytical and detail-oriented mindset, with strong problem-solving and decision-making abilities.
Clear and professional communication, accountability, and ownership.
Ability to work independently and within cross-functional teams.
Proficiency in Google Workspace.
Ability to meet the role's hazardous-drug PPE and respiratory-protection requirements, including obtaining medical approval to wear respiratory protection.
Willingness to confirm understanding of the potential risks of handling hazardous drugs.
Ability to meet the stated physical demands, including lifting up to 50 pounds.

Nice To Haves

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

Responsibilities

Investigate customer complaints and quality-related events, working with pharmacists to assess product quality events.
Lead, document, and coordinate investigations of deviations, nonconformances, complaints, out-of-specification results, and other quality events.
Perform structured root cause analyses to determine the true causes of events.
Ensure investigations are initiated, progressed, and closed 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 CAPAs 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 in a timely manner.
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 trends across investigations 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.