Quality Control Specialist

Hims & Hers•Gilbert, AZ

1d•Onsite

About The Position

Hims & Hers is seeking a highly motivated Quality Control Operations Specialist to support and report to the Senior Manager Quality Operations. This role is responsible for inspecting and/or testing products before, during, and after manufacturing to ensure they meet company and regulatory standards. The position involves performing and leading activities on the production floor to disposition products and raw materials, ensuring compliance with Quality Assurance (QA) policies, USP, SOPs, and cGMP where applicable. The shift for this role is Sunday - Wednesday, 5:30 PM - 4:00 AM.

Requirements

B.S. in chemistry, biology, quality management, engineering, or related discipline preferred.
2+ years of experience in 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 a regulated environment with knowledge of FDA 21, CFR 210, and 211 is a plus.
Excellent interpersonal skills and communication skills (verbal and written).
Solid understanding of product testing, including 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 experience.
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.

Responsibilities

Perform in-process and post-production quality checks, including testing, assessing, and dispositioning products on the production 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 the 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, and implementing corrective action and training activities.
Document and review records, including SOP generation, batch record review, COA acceptance, and USP monographs.
Detect training needs and provide reports to the Site Manager to ensure compliance with quality standards.
Assist with incoming raw material inspections, including implementing procedures for sampling, and guidelines for collection, testing, and reporting quality data.
Assist with drafting SOPs and protocols to adhere to internal policies, USP, and other applicable regulatory guidelines.
Ensure compliance with USP <795> and cGMP cleaning standards.
Assist in audit activities with third-party and internal audits as required.
Assist with the management and reporting of samples to be tested with contract laboratories.