Description
Hims & Hers is seeking an experienced Senior Quality Control Specialist, Gummies to join our Quality Unit located in Mesa, Arizona.
The Senior Quality Control Specialist, Gummies role is responsible for inspecting and testing products before, during, and after compounding processes to ensure products align with company and regulatory standards.
Responsibilities:
- Leads cross-functional initiatives from concept to execution of QC oversight of gummy compounding process
- Escalation management of compounding challenges to appropriate stakeholders
- Drives alignment across teams to create enhanced quality parameters related to gummy compounding
- Perform in-process and post-production quality checks, including testing, assessing products in the compounding suites to ensure product acceptability
- Perform line clearance, where applicable
- 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 Quality processes
- Support change control system to provide improvement solutions
- Support quality processes in the pharmacy – including inspections, pH meters and scale checks, 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.
- Recommend training needs, provide reports to QC Supervisor and Lead Pharmacist to ensure compliance with quality standards
- Ensures compliance with USP <795>, USP <800> and cGMP cleaning standards, where applicable
- Assist in audit activities with all appropriate third-party audits & internal audits as required to ensure compliance
- Assist with the management of samples to be tested with contract laboratories related to process validation
Requirements:
- B.S. in chemistry, microbiology, biology, quality management, engineering, or related discipline
- 1-3 years Gummy formulation/process control experience in a regulated environment
- 3+ years experience in the area of quality assurance/control, process/quality engineering, and/or product formulation
- 1-3 years leading process improvements within a regulated facility
- Experience using pH meter, water activity meter, Brix refractometer
- A Pharmacy Technician license or ability to obtain one within the first six months of employment
- Working knowledge of USP-NF standards <795>, and <800> including monographs
- Excellent interpersonal skills, communication skills, and technical writing
- Solid understanding of product testing including understanding best practices for testing product against defined specifications
- Solid computer skills with Word, Excel, PowerPoint, and Google platform applications
- 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 good documentation practice and facility auditing
Benefits:
- 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)
- 401k benefits with employer matching contribution