Quality Control Specialist, Sterile (Nights)

Hims & Hers • New Albany, OH

12d • Onsite

About The Position

Hims & Hers is seeking an experienced Quality Control Specialist to join its Quality Unit in New Albany, Ohio. The role focuses on continuous improvement and ensuring products meet company and regulatory standards. The specialist inspects and tests products before, during, and after manufacturing, supports product and raw-material disposition, and performs other quality operations in compliance with Quality Assurance policies and procedures, USP standards, SOPs, and applicable cGMP requirements. The role also assists with environmental monitoring programs and reports to the Quality Control Manager. This position is on the night shift.

The position requires working with hazardous drugs and wearing appropriate personal protective equipment. Medical approval is required to wear respiratory protection. The role involves physical exertion, including prolonged standing, walking, squatting, bending, and lifting during shifts of up to twelve hours, with lifting of up to 50 pounds. Employees must also confirm that they understand the potential reproductive, teratogenic, and carcinogenic risks associated with handling certain hazardous drugs.

Requirements

• At least 2 years of experience in quality assurance/control, process or quality engineering, and/or product formulation.
• A Pharmacy Technician license, or willingness to obtain one within the first six months of employment.
• Ability to manage multiple tasks, with strong time-management and organizational skills.
• Excellent interpersonal, communication, and technical-writing skills.
• Solid understanding of product testing and best practices for testing products against defined specifications.
• Ability to multitask and work independently; highly motivated and self-starting.
• Solid computer skills with Word, Excel, PowerPoint, and Google platform applications.
• Strong decision-making, data-collection and analysis, organizing, and planning skills.
• Working knowledge and application of statistical analysis, including probability and trend analysis.
• Knowledge and experience in documentation and facility auditing.
• Willingness to travel as required.
• Ability to wear required personal protective equipment while working with hazardous drugs.
• Medical approval to wear respiratory protection, including negative- or positive-pressure respirators.
• Ability to perform the stated physical activities and lift up to 50 pounds.
• Willingness to confirm understanding of the potential risks of handling certain hazardous drugs.

Nice To Haves

• Bachelor of Science in chemistry, microbiology, biology, quality management, engineering, or a related discipline.
• Experience in a 503b outsourcing facility or in a cGMP or other regulated environment, with knowledge of FDA 21 CFR Parts 210 and 211.
• Aseptic processing experience and knowledge of ISO 14644.
• Working knowledge and application of USP-NF standards <795>, <797>, and <800>, including monographs.

Responsibilities

• Perform in-process and post-production quality checks, including testing and assessing products in compounding suites.
• Perform line clearance where applicable.
• Perform AQLs during visual inspection.
• Provide reports and trending data to QA management.
• Support departments in reporting, handling, and escalating investigations.
• Support investigations into external manufacturer non-conformances to improve quality processes.
• Manage product retain samples.
• Support the change control system and provide improvement solutions.
• Support pharmacy quality processes, including inspections, pH meter and scale checks, investigations, corrective actions, and training activities.
• Document and review records, including generating SOPs, reviewing batch records, and accepting COAs and USP monographs.
• Recommend training needs and provide reports to the QC Manager and Lead Pharmacist to support compliance with quality standards.
• Assist with incoming raw-material inspections, including collection, testing, and reporting of quality data.
• Assist with drafting SOPs and protocols in accordance with internal global policies, USP, and applicable regulatory guidelines.
• Ensure compliance with USP <795>, USP <797>, USP <800>, and cGMP cleaning standards.
• Assist with third-party and internal audit activities.
• Assist with management of samples sent to contract laboratories for testing.
• Assist with relevant environmental monitoring programs.

Benefits

• Competitive salary and equity compensation for full-time roles.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Comprehensive medical, dental, and vision benefits.
• Parental leave.
• Employee Stock Purchase Program (ESPP).
• 401(k) benefits with employer matching contribution.
• The company covers costs and helps employees obtain the Pharmacy Technician license and trainee hours.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level