QA Specialist, Operations

$65,000 - $65,000/Yr

Hims & Hers - Gilbert, AZ

Full-time - Mid Level

Hybrid - Gilbert, AZ

About the position

Hims & Hers is seeking an experienced Quality Assurance Specialist to join our Quality Unit. The Quality Specialist, Operations will focus on driving continuous improvement efforts that benefit and delight the Hims customer. This role involves overseeing processes within the Quality Management System (QMS) related to Deviations, CAPAs, Effectiveness Checks, and electronic Document Control System, ensuring compliance and supporting product development and commercial products.

Responsibilities

• Perform QA review of Deviation/CAPA/EC ensuring completeness, accuracy, and compliance with cGMP regulations.
• Coach and guide stakeholders for effective initiation, approvals, implementation, and closure of QMS records.
• Review and evaluate corrective/preventive actions (CAPA) including the CAPA effectiveness program.
• Communicate CAPA status to cross-functional departments and external partners.
• Support and/or lead the investigation of complex deviations using root cause analysis techniques.
• Maintain activities to support Document Change Control process, including oversight of controlled document lifecycles.
• Review all Standard Operating Procedures (SOPs) and ensure they are maintained to the latest revisions and format.
• Compile quality metrics for monthly trending and management review meetings.
• Track and trend quality events and records related to Quality Documents and QMS.
• Perform training for QA and stakeholders in QMS processes.
• Review and update SOPs, policies, and standards regularly to ensure compliance with GxP standards and regulations.
• Identify and implement process improvement projects to drive success in Quality Management Systems.
• Assist in inspection readiness activities and play a key role during inspections/audits.

Requirements

• B.S. in chemistry, biology, quality management, engineering, or related discipline preferred.
• 2-5 years' experience in quality assurance/control, and/or process engineering.
• Preferred ASQ CQE certification.
• Working knowledge of relevant regulatory standards and requirements, including USP and 21 CFR 820.
• Familiarity with industry-specific quality standard requirements such as cGMPs and ISO 9001 standards.
• Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals and/or ISO 9001.
• Strong understanding of statistical analysis and quality control methodologies.
• Proficiency in using data analysis tools and software.
• Knowledge of continuous improvement methodologies such as Six Sigma or Lean.
• Strong organizational and time management skills.
• Proficiency in using quality management systems software and tools (LIMs system, EtQ, Trackwise).
• Excellent attention to detail and a methodical approach to problem solving.
• Experience with auditing processes and procedures.
• Excellent communication skills, both written and verbal.

Nice-to-haves

• Experience in the pharmaceutical or healthcare industry.
• Familiarity with electronic quality management systems.

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).
• Employee discounts on Hims & Hers products.
• 401k benefits with employer matching contribution.
• Offsite team retreats.