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hims & hers · 1 day ago

Quality Control Specialist

New Albany, OH

Full-time

Onsite

Entry, Mid Level

2+ years exp

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. They are seeking an experienced Quality Control Specialist to join their Quality Unit, focusing on continuous improvement and ensuring product quality aligns with company and regulatory standards.

Health CareLifestyleMen'sWellnessWomen's

Responsibilities

Perform in process and post production quality checks, including testing, assessing products in the compounding suites (“shop floor”) to ensure product acceptability

Perform line clearance, where applicable

Perform AQLs during the visual inspection process

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

Manage product retain samples

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 Manager and Lead Pharmacist to ensure compliance with quality standards

Assist with incoming raw material inspections, as needed per the guidelines for collection, testing, and reporting quality data

Assist with drafting SOPs and protocols to follow internal global policies, USP and other applicable regulatory guidelines

Ensures compliance with USP , USP , 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 of samples to be tested with contract laboratories

Qualification

Quality AssuranceCGMP knowledgeAseptic processingStatistical analysisProduct testingISO 14644 knowledgeTechnical writingPharmacy Technician licenseComputer skillsInterpersonal skillsTime managementOrganizational skills

Required

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

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

A Pharmacy Technician license or willingness to obtain one within the first six months of employment (we cover costs and will help you obtain your trainee hours)

Experience within a 503b outsourcing facility or experience in cGMP or regulated environment with knowledge of FDA 21CFR 210 and 211, a plus

Aseptic processing experience and knowledge of ISO 14644

Working knowledge of USP-NF standards, including monographs

Ability to manage multiple tasks simultaneously, with strong time management and organizational skills

Excellent interpersonal skills, communication skills and technical writing

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, 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 documentation and facility auditing

Some travel may be required

This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs

This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR)

Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs

Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs