Quality Assurance Specialist
5 days ago
Hims & Hers is seeking a highly motivated Quality Control Specialist to join our Quality Unit located in Los Alamitos, CA. The successful candidate will be responsible for driving continuous improvement efforts that benefit and delight the Hims customer.
Key Responsibilities- Perform in-process and post-production quality checks, including testing, assessing, and dispositioning products in the production suites 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 and 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.
- Ensure compliance with USP 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.
- 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 , , 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 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.
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