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Specialist, Quality Control Operations

1 month ago

Gilbert, United States hims & hers Full time

Hims & Hers Health, Inc. (better known as Hims & Hers) is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are revolutionizing telehealth for providers and their patients alike. Making personalized solutions accessible is of paramount importance to Hims & Hers and we are focused on continued innovation in this space. Hims & Hers offers nonprescription products and access to highly personalized prescription solutions for a variety of conditions related to mental health, sexual health, hair care, skincare, heart health, and more.

**About the Role**:
Hims & Hers is seeking an experienced Quality Control Operations Specialist to join our Quality Unit located in Gilbert, AZ. The position of Quality Control Operations Specialist will focus on driving continuous improvement efforts that benefit and delight the Hims customer. We are looking for a highly motivated individual to help support and report to the Senior Manager Quality Operations. The Quality Control Operations Specialist role is responsible for the inspecting and/or testing of product(s) before, during and after manufacturing process(es) to ensure products align with company and regulatory standards, as well as other processes necessary to quality operations. The position performs and leads activities "on the floor" in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, USP, SOPs, and where applicable cGMP.

**Available Shifts**:
**Day Shift: In the Gilbert, AZ facility**

Monday-Friday: 6:30am-4:00pm PST- You must be flexible and open to being scheduled between 6:30am-4:00pm PST. The 8 hour shift you're scheduled depends on production needs

**Night Shift: In the Gilbert, AZ facility**

5:00pm-4:00am PST

***:
**You Will**:

- Perform in process and post production quality checks, including testing, assessing and dispositioning products in the production suites ("shop floor") to ensure product acceptability.
- 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 Hims Quality processes.
- Manage Hims Product Retains and inspections
- Support change control system to provide improvement solutions
- Support quality processes in the pharmacy - including testing inspections, verification of pH meters and scales, 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.
- Detect training needs, provide reports to Site Manager to ensure compliance with quality standards
- Assist with incoming raw material inspections: Implement procedures of sampling (where applicable) and guidelines for collection, testing, and reporting quality data
- Assist with drafting SOPs to follow internal policies, USP and other applicable regulatory guidelines
- Ensures compliance with USP
and
cleaning standards
- Assist in audit activities with all appropriate third party audits & internal audits as required to ensure compliance.

**You Have**:

- B.S. in chemistry, biology, quality management, engineering, or related discipline preferred plus 1-2 years experience in the area of quality assurance/control, process engineering, and/or product formulation
- Working knowledge of USP-NF standards
,
,
including monographs
- Experience in cGMP or regulated environment with knowledge of FDA 21 CFR 820 a plus
- Excellent interpersonal skills and communication skills (verbal and written)
- Solid understanding of product testing including understanding best practices for testing product against defined specifications
- Ability to multi-task and work independently. Highly motivated self-starter.
- Solid computer skills with Word, Excel, Visio, PowerPoint, and Outlook. MRP,
- Excellent skills in decision making, data collection and analysis, organizing and planning.
- Knowledge and experience in technical writing
- Knowledge and experience in Auditing
- Some travel may be required

**Our Benefits (there are more but here are some highlights)**:

- 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)
- Employee discounts on hims & hers & Apostrophe online products
- 401k benefits with employer matching contribution
- Offsite team retreats
- Conditions of Employment:_
- This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.

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