About us: Hims & Hers is a telehealth company that offers a modern approach to health and wellness. Our mission is to make it easier for people to access care and treatment for conditions that impact their daily lives. We’ve created an open and honest culture of care that is accessible for everyone, no matter who they are or where they live. Launched in November 2017, Hims & Hers is one of the fastest growing direct-to-consumer brands in history. To find out more about our brand and offerings, you can visit forhims.com and forhers.com.
Hims & Hers is seeking an experienced Quality Control Operations Specialist to join our Quality Unit. 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.
- 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 <795> and <800> cleaning standards
- Assist in audit activities with all appropriate third party audits & internal audits as required to ensure compliance.
- 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 <795>, <797>, <800> 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.
- Working knowledge and application of statistical analysis including probability and trend analysis
- Knowledge and experience in technical writing
- Knowledge and experience in Auditing
- Some travel may be required
We are focused on building a diverse and inclusive workforce. If you’re excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.
is an Equal Opportunity Employer and considers applicants for employment without regard to race, color, religion, sex, orientation, national origin, age, disability, genetics or any other basis forbidden under federal, state, or local law. Hims considers all qualified applicants in accordance with the San Francisco Fair Chance Ordinance
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee discount
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Retirement plan
- Vision insurance
Experience level:
Schedule:
Work setting:
- In-person
- Manufacturing facility
Application Question(s):
- Are you willing to work onsite in Gilbert, AZ five days per week? (Note: Please answer "Yes" or "No".)
- Do you have experience with the production of tablets/pills and/or working with API? (Note: Please answer "Yes" or "No".)
- Do you have 3+ years of experience in pharmaceutical production and data analysis? (Note: Please answer "Yes" or "No".)
- Do you have hands-on experience using pH meters? (Note: Please answer "Yes" or "No".)
- We are a 503A compounding pharmacy. This means that anyone handling pharmaceuticals may be required to have pharmacy tech licensure. If required, are you willing to obtain a pharmacy tech license (we’ll cover the cost)?
Shift availability:
- Day Shift (Preferred)
- Night Shift (Preferred)
Ability to Relocate:
- Gilbert, AZ 85295: Relocate before starting work (Required)
Work Location: In person