Quality Control Specialist

Hims & Hers is seeking a highly motivated Quality Control Specialist to support and report to the Senior Manager Quality Operations. The successful candidate will be responsible for inspecting and testing products before, during, and after the manufacturing process to ensure compliance with company and regulatory standards.

Responsibilities:

• Perform in-process and post-production quality checks, including testing and dispositioning products.
• Provide reports and trending data to QA management.
• Support external manufacturer non-conformance investigations.
• Manage product retains and inspections.
• Document and review records, including SOP generation and batch record review.
• Detect training needs and provide reports to Site Manager.
• Assist with incoming raw material inspections.
• Assist with drafting SOPs and protocols.
• Ensure compliance with USP <795> and cGMP cleaning standards.
• Assist in audit activities.
• Assist with the management and reporting of samples to be tested with contract laboratories.

Requirements:

• B.S. in chemistry, biology, quality management, engineering, or related discipline preferred.
• 2+ years experience in quality assurance/control, process engineering, and/or product formulation.
• Experience within a 503b outsourcing facility.
• Aseptic processing experience and knowledge of ISO 14644.
• Working knowledge of USP-NF standards <795>, <797>, <800>.
• Experience in cGMP or regulated environment with knowledge of FDA 21, CFR 210, and 211.
• Excellent interpersonal and communication skills.
• Solid understanding of product testing and best practices.
• Ability to multi-task and work independently.
• Highly motivated self-starter with solid computer skills.
• Working knowledge and application of statistical analysis.
• Knowledge and experience in technical writing and auditing.

Benefits:

• Competitive pay with equity compensation.
• ESPP Plan.
• Flexible PTO.
• Holidays observances.
• Quarterly Mental Health Days.
• High-coverage medical, dental & vision.
• Pet Insurance.
• One Medical Membership.
• Disability Benefits.
• Employee Assistance Program.
• Life and AD&D Benefits.
• Fitness stipend.
• Backup childcare.
• Family forming resources.