8 дней назад
Quality Control Operations Specialist (Pharmaceutical Quality)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Control Operations Specialist (Pharmaceutical Quality): Inspecting and testing products and raw materials throughout manufacturing and pharmacy operations with an accent on cGMP compliance, USP standards, investigations, and product disposition. Focus on conducting shop-floor quality checks, reviewing batch records and SOPs, analyzing quality trends, and supporting audits and corrective actions.
Location: Gilbert, Arizona, United States; on-site. Shift: Sunday–Wednesday, 5:30 p.m.–4:00 a.m. Some travel may be required.
Company
Hims & Hers is a public health and wellness platform providing personalized access to diagnosis, treatment, and delivery.
What you will do
- Perform in-process and post-production quality checks, testing, assessment, and product disposition on the production floor.
- Support quality operations in the pharmacy, including inspections, verification of pH meters and scales, investigations, complaints, corrective actions, and training.
- Manage product retains, incoming raw material inspections, sampling procedures, and quality data reporting.
- Prepare and review SOPs, batch records, certificates of analysis, USP monographs, protocols, and other quality documentation.
- Support non-conformance, deviation, change-control, and external manufacturer investigations.
- Assist with internal and third-party audits and coordinate samples submitted to contract laboratories.
Requirements
- Bachelor’s degree in chemistry, biology, quality management, engineering, or a related discipline preferred.
- At least 2 years of experience in quality assurance or control, process engineering, and/or product formulation.
- Experience in a 503B outsourcing facility, aseptic processing, and ISO 14644 knowledge.
- Working knowledge of USP-NF standards <795>, <797>, and <800>, including monographs.
- Product testing, technical writing, auditing, statistical analysis, data collection, and trend analysis skills.
- Ability to work independently, manage multiple tasks, communicate effectively, and use Word, Excel, Visio, PowerPoint, Outlook, and MRP systems.
Nice to have
- Experience in a cGMP or regulated environment with knowledge of FDA 21 CFR 210 and 211.
Culture & Benefits
- Collaborative, open, and honest culture that values diverse perspectives.
- Competitive pay with equity compensation and an employee stock purchase plan.
- Flexible paid time off, holidays, and quarterly mental health days.
- Medical, dental, and vision coverage with FSA and HSA options.
- Pet insurance, One Medical membership, disability and life benefits, fitness stipend, backup childcare, and family-forming resources.
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