Quality Assurance Specialist

Hims & Hers • New Albany, OH

1d • Remote

About The Position

The Quality Assurance Specialist supports the Hims & Hers Quality team by building and maintaining data-driven quality performance systems that ensure our compounding and fulfillment operations consistently meet internal standards and regulatory requirements. This role is responsible for monitoring, analyzing, and reporting key quality metrics and KPIs related to RCAs, CAPA, deviations, supplier quality, product release, environmental monitoring, and compliance performance. The QA Specialist acts as the bridge between data and action — transforming quality insights into measurable improvements that enhance safety, compliance, and operational efficiency.

Requirements

• Bachelor’s degree in Quality Assurance, Data Analytics, Engineering, Life Sciences, or a related field required.
• 3+ years in pharmaceutical, compounding, medical device, or regulated healthcare environments.
• Strong understanding of Quality Management Systems (QMS) and cGMP compliance.
• Experience analyzing and visualizing data using Excel, Power BI, Tableau, or similar platforms.
• Familiarity with USP <795>, <797>, <800>, 21 CFR Part 211, and Good Documentation Practices (GDP).
• Strong analytical, organizational, and problem-solving skills.
• Excellent attention to detail and ability to interpret complex datasets.
• Proficient in data visualization and KPI reporting.
• Strong communication and presentation abilities across departments.
• Experience with ERP and QMS software (e.g., NetSuite, MasterControl, TrackWise, Veeva).

Responsibilities

• Develop & Maintain Quality Metrics: Create, track, and report on key performance indicators (KPIs) related to quality system effectiveness, including CAPA cycle time, audit findings, deviation trends, and complaint resolution rates.
• Data Analysis & Reporting: Aggregate and analyze quality data from multiple systems to identify trends, process gaps, and improvement opportunities.
• Continuous Improvement: Partner with QA leadership and Operations to implement corrective and preventive actions (CAPAs) based on metric trends and root cause analysis.
• Regulatory Alignment: Ensure KPI programs are aligned with cGMP, BOF, and USP <795>, <797>, <800> standards, supporting inspection readiness and ongoing compliance.
• Dashboard Management: Design and maintain dashboards and scorecards that visualize key quality metrics for leadership review and internal audits.
• Process Optimization: Work cross-functionally to standardize data collection, streamline reporting workflows, and automate metrics tracking where feasible.
• Audit & Inspection Support: Provide metric summaries and trend data to support internal, external, and regulatory audits.
• Training & Engagement: Support training initiatives to ensure teams understand quality KPIs, expectations, and improvement targets.

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level