Quality Control Specialist (Sterile)

TL;DR

Quality Control Specialist (Sterile Production): Performing quality inspections and testing of sterile healthcare products with an accent on regulatory compliance and sterile compounding standards. Focus on maintaining USP and cGMP adherence, managing non-conformance investigations, and ensuring product acceptability in a high-stakes aseptic environment.

Location: On-site in New Albany, Ohio

Company

A leading health and wellness platform redefining healthcare by providing affordable and personalized access to care from diagnosis to delivery.

What you will do

• Perform in-process and post-production quality checks and testing within compounding suites to ensure product acceptability.
• Execute line clearances and AQLs during visual inspection processes.
• Provide reports and trending data to QA management and support the escalation of investigations.
• Manage product retain samples and support the change control system to implement improvement solutions.
• Ensure strict compliance with USP <795>, <797>, <800> and cGMP cleaning standards.
• Assist with incoming raw material inspections and support internal and third-party audit activities.

Requirements

• B.S. in chemistry, microbiology, biology, quality management, engineering, or a related discipline (preferred).
• 1-3 years of experience in QA/QC or product formulation within a sterile environment.
• Pharmacy Technician license or willingness to obtain one within the first six months of employment.
• Knowledge of aseptic processing, ISO 14644, and USP-NF standards.
• Ability to work the night shift (6:00pm to 6:30am) on a 3-2-2-3 schedule.
• Medical approval to wear respiratory protection (N95, PAPR, etc.) and ability to lift up to 50lbs.

Culture & Benefits

• Competitive salary and 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.
• 401(k) with employer matching contribution.
• Employee Stock Purchase Program (ESPP).