Quality Assurance Specialist, Operations

​​About the Role:

Hims & Hers is seeking an experienced Quality Assurance Specialist to join our Quality Unit. The position of Quality Specialist, Operations will focus on driving continuous improvement efforts that benefit and delight the Hims customer. We are looking for a highly motivated individual to help support and report to the Senior Manager Quality Operations. This role will oversee the processes within the QMS related to Deviations, CAPAs, Effectiveness Checks, and electronic Document Control System. This includes process design, monitoring for compliance, continuous improvement activities, metrics, and day-to-day operations for the specified Quality processes. He/she will be responsible for Quality related activities for product development and commercial products.

You Will:

• Performs QA review of Deviation/CAPA/EC. Ensures completeness, accuracy, and compliance to all applicable cGMP regulations. Coaches and guides stakeholders to ensure effective initiation, approvals, implementation and closure of QMS records per applicable procedures and regulations.
• Reviews and evaluates corrective/preventive actions (CAPA) including the CAPA effectiveness program. Responsible for communicating CAPA status to cross-functional departments and external partners
• Supports and/or leads the investigation of complex deviations. Ensures thorough investigations are conducted using various root cause analysis techniques and that all investigations are technically sound/properly documented, with corrective actions for prevention of reoccurrence identified
• Maintains activities to support Document Change Control process, including oversight of controlled document lifecycles, document change requests, classification, and on time periodic review.
• Reviews all Standard Operating Procedures (SOPs), forms, templates, reports, standard test methods and specifications, and technical documents, as applicable, ensuring all documents are maintained to latest revisions and format.
• Supports compilation of quality metrics for monthly trending, management review meetings and follow up for the closure of process improvements. Presentation and communication of trending reports in respective Quality forums.
• Tracks and trends quality events and records related to Quality Documents and QMS.
• Performs training for QA and stakeholders in QMS processes.
• Reviews and updates SOPs, policies, and standards regularly to ensure compliance with GxP standards, FDA/BOP/USP and other applicable competent authority regulations and requirements
• Identifies and implements process improvement projects to drive success in the areas of Quality Management Systems.
• Assists in inspection readiness activities and plays a key role during inspections/audits
• Provides support during internal review, Audits, FDA Audits and Third-party consultant Audits
• Role will be cross trained on all QMS processes (Document Control, Deviation/CAPA/EC, and Change Control) and will act as QA approver/reviewer as required.
• Assigned duties/projects, as needed, to support continuous quality improvements.

You Have:

• B.S. in chemistry, biology, quality management, engineering, or related discipline preferred plus 2-5 years’ experience in the area of quality assurance/control, and/or process engineering
• Preferred ASQ CQE certification
• Working knowledge of relevant regulatory standards and requirements. USP <795>, <800>, <797>
• Familiarity with industry specific quality standard requirements to include a working knowledge of 21 CFR 820, cGMPs, ISO 9001 standards, as well as the Drug Quality & Security Act
• 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, with the ability to prioritize and manage multiple tasks simultaneously.
• Proficiency in using quality management systems software and tools (LIMs system, EtQ, Trackwise)
• Excellent attention to detail and a methodical and systematic approach to problem solving
• Experience with auditing processes and procedures
• Excellent communication skills, both written and verbal, with the ability to convey complex ideas and concepts to cross-functional teams

Our Benefits (there are more but here are some highlights):

• 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 & Apostrophe online products
• 401k benefits with employer matching contribution
• Offsite team retreats

Conditions of Employment: 

• This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.
• This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).
• Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.
• Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.