Apply on Employer Site

hims & hers · 2 days ago

QA Investigations Specialist

United States

Full-time

Remote

Mid Level

3+ years exp

Hims & Hers is a leading health and wellness platform dedicated to improving healthcare access. The QA Investigations Specialist will lead investigations into quality-related events, ensuring compliance with regulatory standards and collaborating across teams to enhance quality systems and practices.

Health CareLifestyleMen'sWellnessWomen's

Responsibilities

Lead, document, and coordinate investigations of deviations, nonconformances, complaints, OOS, and other quality events

Perform structured root cause analyses to determine true causes

Ensure timely initiation, progress, and closure of investigations within defined quality system timelines

Collaborate with production, QC laboratory, and QA to gather evidence and assess event impact

Identify and recommend appropriate CAPAs to prevent recurrence of issues

Ensure CAPA actions are practical, risk-based, and aligned with regulatory and company standards

Track CAPA implementation and verify effectiveness

Prepare clear, accurate, and 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 closely with QA, QC, and Quality Systems to ensure consistent application of investigation procedures

Facilitate communication between operations, technical teams, and quality groups during investigations

Participate in site-level quality review boards or investigation review committees

Identify trends across investigations and recommend systemic improvements

Support training of staff on deviation reporting, investigation practices, and documentation standards

Contribute to enhancement of site procedures for deviation and OOS management

Qualification

Quality AssuranceRoot Cause AnalysisCGMP StandardsFDA RegulationsQuality Systems SoftwareInvestigations ExperienceAttention to DetailDocumentation PracticesInterpersonal SkillsTechnical WritingCollaboration SkillsProblem-Solving

Required

Bachelor's degree in a relevant discipline (science, quality, or engineering-related field) or equivalent combination of education and experience

3+ years of related experience in quality, manufacturing, or a regulated industry

Excellent attention to detail, documentation practices, and organizational skills

Experience with investigations, deviation management, and escalation procedures

Proficiency in Google Workspace and familiarity with quality systems software

Strong interpersonal and communication skills (written and verbal)

Pharmacy Technician or trainee license or willingness to acquire

Excellent written communication and technical writing skills

Strong collaboration skills across multidisciplinary teams

Ability to manage multiple investigations under tight timelines

Preferred

Bachelor's degree preferred in a relevant discipline (science, quality, or engineering-related field) or equivalent combination of education and experience

3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree

Strong understanding of USP , , standards, FDA 21 CFR Parts 210 & 211, and cGMP

GDP and GLP practices preferred

Proficiency in electronic quality systems (e.g., TrackWise, MasterControl) preferred