# Quality Control Specialist, Sterile (Nights) **Company**: Hims & Hers **Location**: New Albany, Ohio **Work arrangement**: onsite **Experience**: mid **Job type**: Full time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://jobs.ashbyhq.com/hims-and-hers/b54746ed-581b-4509-92ed-8f911a035f0b?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_a18eaae2-3c8 ## Description Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. ## About the Role: Hims & Hers is seeking an experienced Quality Control Specialist to join our Quality Unit located in New Albany, Ohio. The position of Quality Specialist will focus on driving continuous improvement efforts that benefit and delight the Hims customer. The Quality Specialist role is responsible for inspecting and/or testing of product(s) before, during, and after the manufacturing process(es) to ensure products align with company and regulatory standards. ## Responsibilities: - Perform in-process and post-production quality checks, including testing, assessing products in the compounding suites to ensure product acceptability. - Perform line clearance, where applicable. - Perform AQLs during the visual inspection process. - 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 Quality processes. - Manage product retain samples. - Support change control system to provide improvement solutions. - Support quality processes in the pharmacy – including inspections, pH meters, and scale checks, non-conformance/deviation/complaint investigations, implement corrective action activities, training activities, etc. - Document & review of records: SOP generation, batch record review, COA acceptance, USP monographs, etc. - Recommend training needs, provide reports to QC Manager and Lead Pharmacist to ensure compliance with quality standards. - Assist with incoming raw material inspections, as needed per the guidelines for collection, testing, and reporting quality data. - Assist with drafting SOPs and protocols to follow internal global policies, USP, and other applicable regulatory guidelines. - Ensures compliance with USP <795>, USP <797>, USP <800> and cGMP cleaning standards. - Assist in audit activities with all appropriate third-party audits & internal audits as required to ensure compliance. - Assist with the management of samples to be tested with contract laboratories. ## Requirements: - B.S. in chemistry, microbiology, biology, quality management, engineering, or related discipline preferred. - 2+ years of experience in the area of quality assurance/control, process/quality engineering, and/or product formulation. - A Pharmacy Technician license or willingness to obtain one within the first six months of employment. - Experience within a 503b outsourcing facility or experience in cGMP or regulated environment with knowledge of FDA 21CFR 210 and 211, a plus. - Aseptic processing experience and knowledge of ISO 14644. - Working knowledge of USP-NF standards <795>, <797>, <800> including monographs. - Ability to manage multiple tasks simultaneously, with strong time management and organizational skills. - Excellent interpersonal skills, communication skills, and technical writing. - Solid understanding of product testing, including understanding best practices for testing product against defined specifications. - Ability to multitask and work independently. - Solid computer skills with Word, Excel, PowerPoint, and Google platform applications. - Excellent skills in decision making, data collection and analysis, organizing, and planning. - Working knowledge and application of statistical analysis, including probability and trend analysis. - Knowledge and experience in documentation and facility auditing. - Some travel may be required. ## 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). - 401 (k) benefits with employer matching contribution. ## Skills ### Required - chemistry - microbiology - biology - quality management - engineering - USP <795> - USP <797> - USP <800> - cGMP - FDA 21CFR 210 and 211 - ISO 14644 - statistical analysis - documentation - facility auditing ### Nice to have - Pharmacy Technician license - 503b outsourcing facility experience - aseptic processing experience --- Source: [Apply at jobs.ashbyhq.com](https://jobs.ashbyhq.com/hims-and-hers/b54746ed-581b-4509-92ed-8f911a035f0b?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)