QA Investigations Specialist

About Hims & Hers

Hims & Hers is a leading health and wellness platform committed to enhancing global health by providing affordable, accessible, and individualized care. Emphasizing a customer-first approach, the company provides personalized healthcare solutions from diagnosis through treatment and delivery. Hims & Hers believes in normalizing wellness challenges and innovating for improved health outcomes.

Role Overview

The QA Investigations Specialist will lead and support investigations related to quality incidents within both 503A and 503B compounding pharmacy environments. This role works closely with Quality Assurance, Quality Control, and Quality Systems teams to conduct thorough root cause analysis, document findings accurately, and implement resolutions for deviations, nonconformances, out-of-specification results, and other quality matters. Responsibilities include ensuring all investigations comply with regulatory requirements such as USP, FDA 503B guidance, and cGMP regulations.

Primary Responsibilities

• Lead and document investigations of deviations, nonconformances, complaints, OOS, and other quality issues.
• Conduct structured root cause analysis to identify true causes of quality events.
• Ensure investigations are initiated promptly and completed within established quality system timelines.
• Collaborate with production, QC labs, and QA teams to collect evidence and evaluate impact.
• Recommend and oversee corrective and preventive actions (CAPA) to prevent recurrence, ensuring they are risk-based and compliant with regulations.
• Track CAPA progress and verify effectiveness upon implementation.
• Prepare compliant, clear, and detailed investigation reports under SOPs and regulatory guidelines.
• Maintain comprehensive records to support audits and regulatory inspections.
• Escalate significant quality issues to leadership promptly.
• Facilitate communication across operations, technical teams, and quality departments during investigations.
• Participate in site quality review boards or investigation committees.
• Identify patterns across investigations and propose systemic improvements.
• Support staff training on deviation reporting, investigation techniques, and documentation standards.
• Enhance site procedures related to deviation and OOS management continuously.

Qualifications

• Bachelor’s degree preferably in science, quality, or engineering fields or equivalent education and experience.
• At least 3 years’ experience in quality, manufacturing, or regulated industries can substitute for degree requirement.
• Comprehensive knowledge of USP standards, FDA 21 CFR Parts 210 & 211, FDA 503B guidance, and cGMP; familiarity with GDP and GLP favored.
• Meticulous attention to detail with strong documentation and organizational skills.
• Experience managing investigations, deviations, and escalation procedures.
• Proficient with Google Workspace and quality management software.
• Excellent verbal and written communication skills, including technical writing.
• Preferably holds or is willing to obtain a Pharmacy Technician or trainee license.
• Ability to manage multiple concurrent investigations under strict deadlines.
• Experience with electronic quality systems such as TrackWise or MasterControl is a plus.

Key Competencies

• Strong analytical thinking and attention to detail.
• Effective problem-solving and decision-making capabilities.
• Professional and clear communication skills.
• High accountability and ownership of responsibilities.
• Capability to work both independently and collaboratively within cross-functional teams.

Employee Benefits

• Competitive salary and equity packages for full-time employees.
• Unlimited paid time off, official company holidays, and quarterly mental health days.
• Comprehensive medical, dental, vision insurance, and parental leave.
• Employee Stock Purchase Plan (ESPP).
• 401(k) plan with employer matching contributions.
• Company-sponsored offsite team retreats.

Diversity and Legal Commitments

Hims & Hers is dedicated to fostering a diverse workforce with a strong ethical foundation and a supportive environment. All qualified applicants will be considered fairly, including those with arrest or conviction records according to applicable fair chance laws. The company respects the privacy and rights of applicants requiring disability accommodations during the hiring process and complies with relevant laws prohibiting lie detector tests as conditions for employment.