Quality Control Specialist, Sterile (Nights)

The role

The Quality Control Specialist inspects and tests products before, during, and after manufacturing to ensure compliance with company and regulatory standards. This role performs activities on the shop floor to support product disposition and environmental monitoring.

What you will do

• Perform in-process and post-production quality checks in compounding suites
• 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
• Manage product retain samples
• Support change control system
• Support quality processes in the pharmacy including inspections and scale checks
• Document and review records including SOP generation and batch record review

Required qualifications

• 2+ years of experience in quality assurance/control, process/quality engineering, and/or product formulation
• Aseptic processing experience and knowledge of ISO 14644
• Working knowledge of USP-NF standards, including monographs
• Ability to manage multiple tasks simultaneously
• Strong time management and organizational skills
• Excellent interpersonal skills, communication skills, and technical writing
• Solid understanding of product testing against defined specifications
• Ability to multitask and work independently
• Solid computer skills with Word, Excel, PowerPoint, and Google platform applications
• Skills in decision making, data collection and analysis, organizing, and planning
• Working knowledge and application of statistical analysis
• Knowledge and experience in documentation and facility auditing

Nice to have

• B.S. in chemistry, microbiology, biology, quality management, engineering, or related discipline
• Experience within a 503b outsourcing facility or experience in cGMP or regulated environment with knowledge of FDA 21CFR 210 and 211

Benefits

• Competitive salary & equity compensation
• Unlimited PTO
• Company holidays
• Quarterly mental health days
• Comprehensive health benefits including medical, dental & vision
• Parental leave
• Employee Stock Purchase Program (ESPP)
• 401 (k) benefits with employer matching contribution

Before you apply

• Requires working with Hazardous Drugs (HD) wearing Personal Protective Equipment (PPE)
• Requires medical approval to wear respiratory protection
• Must be willing to confirm understanding of potential risks of handling hazardous drugs
• Physical exertion required including standing up to 100% of the time and lifting up to 50lbs

About the company

Hims & Hers is a health and wellness platform that provides access to affordable, accessible, and personal healthcare. The company is a public company traded on the NYSE.