Quality Control Specialist

hims & hers; Gilbert (AZ); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Equity compensation

ESPP Plan

Flexible PTO

Medical, dental & vision coverage

Pet Insurance

One Medical Membership

Disability Benefits

Employee Assistance Program

Job summary

Hims & Hers is seeking a Quality Control Operations Specialist to inspect and test products throughout manufacturing, ensuring adherence to QA policies, USP, and cGMP standards. The role supports dispositioning materials on the shop floor and leads investigations with QA management.

You will: perform in-process quality checks, generate reports, support CAPA activities, and draft SOPs to align with USP and FDA standards. Shift is Sunday–Wednesday, 5:30pm–4:00am.

Qualifications

• B.S./B.A. science or QA related degree preferred.
• 2+ years in quality assurance/control, process engineering, or product formulation.
• Experience in a regulated facility with GMP/ISO standards is a plus.
• Strong written and verbal communication; ability to document and audit.
• Knowledge of USP-NF, ISO 14644, and FDA CFR standards is advantageous.

Responsibilities

• Perform in-process and post-production quality checks on products on the shop floor.
• Provide QA reports and trend data to management; assist investigations.
• Support external manufacturer non-conformance investigations to improve quality.
• Manage product retains, sampling, and testing procedures; support CAPA activities.
• Draft SOPs and ensure compliance with USP and cGMP guidelines.
• Assist with audits and with testing samples through contract labs.

Skills

Quality assurance

Documentation

Data analysis

Communication

Multi-tasking

FDA/cGMP knowledge

Auditing

Education

B.S. in chemistry/biology/quality management/engineering

Tools

MS Office (Word, Excel, PowerPoint, Outlook)

MRP

Visio

Job 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. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve.

Hims & Hers is a public company, traded on the NYSE under the ticker symbol "HIMS." To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works. For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.

About the Role:

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.

Shift : Sunday - Wednesday 5:30pm - 4:00am

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 and protocols to follow internal policies, USP and other applicable regulatory guidelines Ensures compliance with USP <795> 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 and reporting of samples to be tested with contract laboratories.

You Have:

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

• 2+ years experience in the area of quality assurance/control, process engineering, and/or product formulation

• Experience within a 503b outsourcing facility Aseptic processing experience and knowledge of ISO 14644 Working knowledge of USP-NF standards <795>, <797>, <800> including monographs Experience in cGMP or regulated environment with knowledge of FDA 21, CFR 210, and 211 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 independent.

• 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

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

Offering competitive benefits are a top priority for our company; we are extremely proud of the benefits we are able to offer to employees. Some of the benefits our team members are able to enjoy include:

• A dynamic, open & honest culture of collaborative co-workers where diverse perspectives are welcome & valued

• Competitive pay with equity compensation

• ESPP Plan

• Flexible PTO

• Holidays observances

• Quarterly Mental Health Days

• High-coverage medical, dental & vision (FSA & HSA plan options)

• Pet Insurance

• One Medical Membership

• Disability Benefits

• Employee Assistance Program

• Life and AD&D Benefits

• Fitness stipend

• Backup childcare

• Family forming resources

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [e-mail] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.

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