Quality Control Specialist

About This Role

Supporting and reporting to the Senior Manager Quality Operations, this specialist role involves inspecting and testing products before, during, and after manufacturing to ensure alignment with company and regulatory standards. This position performs and leads "on the floor" activities to support product and raw material disposition while ensuring compliance with Quality Assurance (QA) policies and procedures, USP, SOPs, and cGMP where applicable.

Responsibilities

• Perform in-process and post-production quality checks, including testing, assessing, and dispositioning products in the production suites ("shop floor") to ensure product acceptability
• Provide reports and trending data to QA management
• Support departments in reporting, handling, and escalation of investigations
• Support external manufacturer non-conformance investigations to improve Hims Quality processes
• Manage Hims Product Retains and inspections
• Support change control system to provide improvement solutions
• Support quality processes in the pharmacy, including testing inspections, verification of pH meters and scales, non-conformance/deviation/complaint investigations, implement corrective action activities, and training activities
• Document and review records: SOP generation, batch record review, COA acceptance, USP monographs, etc.
• Detect training needs, provide reports to Site Manager to ensure compliance with quality standards
• Assist with incoming raw material inspections: implement procedures of sampling (where applicable) and guidelines for collection, testing, and reporting quality data
• Assist with drafting SOPs and protocols to follow internal policies, USP, and other applicable regulatory guidelines
• Ensure compliance with USP (795) and cGMP cleaning standards
• Assist in audit activities with all appropriate third-party audits and internal audits as required to ensure compliance
• 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 the area of 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) including monographs
• Experience in cGMP or regulated environment with knowledge of FDA 21, CFR 210, and 211 a plus
• Excellent interpersonal and communication skills (verbal and written)
• Solid understanding of product testing, including best practices for testing product against defined specifications