Quality Assurance Investigations Specialist

New Albany, Ohiofull time

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Remote

mid

H1B: no

Hims and Hers Quality Assurance Investigations Specialist at Hims and Hers leads and supports investigations into quality-related events within a 503A compounding pharmacy. The role ensures compliance with regulatory requirements and collaborates cross-functionally to manage deviations, complaints, and CAPA processes.

Responsibilities

We are seeking an experienced Quality Assurance Investigations Specialist to join the Quality Unit at our compounding pharmacy in New Albany, OH. In this role, you will lead and support investigations into quality-related events within our 503A compounding pharmacy operations. Reporting to the Quality Assurance Manager, you will partner closely with Quality Control (QC) and Quality Systems to ensure deviations, nonconformances, complaints, and other quality events are thoroughly investigated with rigorous root cause analysis and complete documentation.
Event Investigation & Root Cause Analysis
Lead, document, and coordinate investigations of deviations, nonconformances, complaints, OOS results, and other quality events.
Investigate customer complaints and quality-related events, working closely with pharmacists to assess product 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, the QC laboratory, and QA to gather evidence and assess event impact.
Corrective and Preventive Actions (CAPA)
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.
Compliance & Documentation

Qualification

Education & ExperiencePharmacy Technician or trainee licenseKnowledge & SkillsStrong understanding of USPExperience with investigationsExcellent attention to detailProficiency in Google Workspace

Required

Education & Experience
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.
Pharmacy Technician or trainee license, or willingness to obtain one.
Knowledge & Skills
Strong understanding of USP , , and standards, FDA 21 CFR Parts 210 & 211, and cGMP; GDP and GLP experience preferred.
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; proficiency with electronic quality systems (e.g., TrackWise, MasterControl) preferred.