Quality Control Specialist, Sterile (Nights)
Hims & Hers· QUALITY
New Albany, OhioFull-timePosted 4d ago
About the role
Experienced Quality Control Specialist for Nights shift in the Sterile team based in New Albany, Ohio, focusing on in-process and post-production quality checks, compliance with QA policies and regulatory standards, and continuous improvement to benefit the customer.
Responsibilities
- Perform in-process and post-production quality checks, including testing, assessing products in the compounding suites ("shop floor") 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
Qualifications
- 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 (we cover costs and will help you obtain your trainee hours)
- 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. Highly motivated self-starter.
- 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
Skills
Required:Quality assurance and controlAseptic processingUSP <795>, <797>, <800>cGMPDocumentation & record reviewTechnical writing
Nice to have:Statistical analysis & trendingPharmacy operations
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
Last updated Oct 21, 2026. Interested? Apply on the company site.
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