Quality Control Specialist, Sterile (Nights)

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health.

Hims & Hers is seeking an experienced Quality Control Specialist to join our Quality Unit located in New Albany, Ohio.

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.

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.