# Quality Control Specialist (Night Shift)

**Company**: Hims & Hers
**Location**: New Albany, Ohio
**Work arrangement**: onsite
**Experience**: mid
**Job type**: Full time
**Category**: Other
**Industry**: Healthcare

**Apply**: https://jobs.ashbyhq.com/hims-and-hers/900d4a34-1d22-43d1-9487-b247d492d572?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_78282d19-bde

## Description

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health.

Hims & Hers is seeking an experienced Quality Control Specialist to join our Quality Unit located in New Albany, Ohio. The position of Quality Specialist will focus on driving continuous improvement efforts that benefit and delight the Hims customer.

## Responsibilities:

- Perform in-process and post-production quality checks, including testing and assessing products to ensure they align with company and regulatory standards.

- Perform line clearance, where applicable.

- Conduct 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, and implement corrective action activities.

- Document and review records, including SOP generation, batch record review, COA acceptance, and USP monographs.

- Recommend training needs and provide reports to QC Manager and Lead Pharmacist to ensure compliance with quality standards.

- Assist with incoming raw material inspections, as needed.

- Assist with drafting SOPs and protocols to follow internal global policies, USP, and other applicable regulatory guidelines.

- Ensure compliance with USP <795>, USP <797>, USP <800>, and cGMP cleaning standards.

- Assist in audit activities with all appropriate third-party audits and internal audits as required to ensure compliance.

- Assist with the management of samples to be tested with contract laboratories.

## Requirements:

- B.S. in chemistry, microbiology, biology, quality management, engineering, or related discipline preferred.

- 1-3 years of 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.

- 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 multi-task and work independently.

- 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.

## 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, and vision, and parental leave.

- Employee Stock Purchase Program (ESPP).

- 401(k) benefits with employer-matching contribution.

## Skills

### Required
- Quality Control
- Regulatory Compliance
- Pharmacy Operations
- Statistical Analysis
- Documentation
- Facility Auditing
- Interpersonal Skills
- Technical Writing
- Computer Skills
- Decision Making
- Data Collection
- Analysis
- Organizing
- Planning

### Nice to have
- 503b outsourcing facility experience
- cGMP experience
- Aseptic processing experience
- ISO 14644 knowledge
- USP-NF standards knowledge

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Source: [Apply at jobs.ashbyhq.com](https://jobs.ashbyhq.com/hims-and-hers/900d4a34-1d22-43d1-9487-b247d492d572?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)