Pharmacy Quality Assurance Associate (Contract)

Hims & Hers is seeking an experienced Pharmacy Quality Assurance Contractor – Rx and Warehouse. You will have the responsibility of creating and implementing quality standards for Hims products. You will focus on driving continuous improvement efforts that benefit and delight Hims customers. In addition, you will provide support for and report to the Senior Quality Assurance Manager and will work with external manufacturers and suppliers to ensure products are produced to Hims standards.

You Will:

• Support the execution and implementation of a Corporate Quality Management System (QMS) software.
• Utilize the Quality GAP analysis to implement short and long-term Quality goals and objectives.
• Prepare and analyze product quality complaints and adverse event data to examine trends and estimate uncertain events. Reports serious or repeated failures to manufacturers, recommends corrective actions, or employs programs for overall defect reduction in products to support customer satisfaction.
• Collaborate with Product Development and R&D team members, review and approve manufacturing, compounding and assembly instructions for products that are adequate inspection points for incoming products and materials.
• Determine, develop and train employees on appropriate inspection points at the warehouse using AQL inspection method techniques.
• Develop and review standards, policies, and procedures for all functions and departments involved with the compounding and manufacturing of Rx products and Warehouse activities.
• Schedule and perform quality audits of compounding pharmacies and raw material vendors. Reports findings to the appropriate teams.
• Provide expert guidance in critical quality areas for product launches, which include but are not limited to testing, documentation, ensuring compliance to regulatory requirements and warehousing principles.
• Coordinate with internal team members in supplier selection, verification and validation processes.
• Build an SOP library for core quality processes for Rx products and warehouse activities.

You Have:

• 5+ years of Quality Assurance experience in Pharmaceuticals, Compounding and Warehouse activities. 
• BS in Chemistry or equivalent science field. A Masters degree is a plus.
• Quality Assurance certifications are a plus.
• Energetic, highly self-motivated and able to work efficiently and productively in a rapidly-growing and fast-moving company.
• Ability to evaluate processes and to facilitate effective change.
• Excellent cross-functional collaboration, communication, and interpersonal skills.
• Strong project management skills.
• Ability to work independently to support quality goals.
• Proficiency in writing and oral presentations.
• Ability to travel as needed approximately 25% of time.

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.