Night-Shift Quality Assurance Specialist

hims-and-hers; Beloit (OH); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Unlimited PTO

Comprehensive health benefits

Employee Stock Purchase Program (ESPP)

401(k) benefits with employer matching

Job summary

Hims & Hers is seeking an experienced Quality Control Specialist to join our Quality Unit in New Albany, Ohio. The role focuses on continuous improvement and ensuring products meet QA, USP, and cGMP standards.

Night shift runs Wed–Sat from 9:00pm to 7:30am, with duties on the shop floor, line clearance, AQLs, and investigations. The candidate will perform in-process checks, manage retention samples, support change control, and assist with QA documentation and training in a regulated pharma

Qualifications

• BS in chemistry, microbiology, biology, quality management, engineering or related discipline preferred.
• 1-3 years experience in 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

Responsibilities

• Perform in-process and post production quality checks, including testing in shop floor areas 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.

Skills

Attention to detail

Interpersonal skills

Communication

Technical writing

Data analysis

Time management

Education

B.S. in chemistry, microbiology, biology, quality management, engineering

Pharmacy Technician license

Tools

pH meters

scales

Job description

Hims & Hers is seeking an experienced Quality Control Specialist to join our Quality Unit in New Albany, Ohio. The role focuses on continuous improvement and ensuring products meet QA, USP, and cGMP standards.

Night shift runs Wed–Sat from 9:00pm to 7:30am, with duties on the shop floor, line clearance, AQLs, and investigations. The candidate will perform in-process checks, manage retention samples, support change control, and assist with QA documentation and training in a regulated pharma