# Quality Control Specialist, Sterile (Nights)

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

**Apply**: https://jobs.ashbyhq.com/hims-and-hers/1d155b91-f16a-4f05-a5a0-a32906a0905b?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_b8d3be0f-760

## 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.

**Responsibilities:**

- Perform in-process and post-production quality checks, including testing, assessing products in the compounding suites 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.

**Requirements:**

- 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.

- 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.

- 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 & 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.

## Skills

### Required
- Quality Control
- Sterile Products
- cGMP
- USP <795>
- USP <797>
- USP <800>
- Aseptic Processing
- ISO 14644
- Statistical Analysis
- Documentation
- Facility Auditing

### Nice to have
- Pharmacy Technician license
- Experience within a 503b outsourcing facility
- Knowledge of FDA 21CFR 210 and 211

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Source: [Apply at jobs.ashbyhq.com](https://jobs.ashbyhq.com/hims-and-hers/1d155b91-f16a-4f05-a5a0-a32906a0905b?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)