Quality Control Specialist, Sterile (Night Shift)

Hims & Hers • New Albany, OH

4d • Onsite

About The Position

Hims & Hers is seeking an experienced Quality Control Specialist, Sterile to join our Quality Unit located in New Albany, Ohio. The position of Quality Specialist will focus on driving continuous improvement efforts that benefit and delight the Hims customer. We are looking for a highly motivated individual to help support and report to the Quality Control Manager. The Quality 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. Assist with relevant environmental monitoring programs. This is a Night Shift Position: 6:00pm to 6:30am with a 3-2-2-3 schedule.

Requirements

• 1-3 years experience in the area of quality assurance/control, process/quality engineering, and/or product formulation in a Sterile environment
• 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).
• Aseptic processing experience and knowledge of ISO 14644
• Working knowledge of USP-NF standards <795>, <797>, <800> 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
• 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. These items would include gloves, respiratory protection, gown, and other items as required.
• 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.

Nice To Haves

• B.S. in chemistry, microbiology, biology, quality management, engineering, or related discipline preferred
• Experience within a 503b outsourcing facility or experience in cGMP or regulated environment with knowledge of FDA 21CFR 210 and 211, a plus
• Some local travel may be required

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 <795>, USP <797>, USP <800> 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.

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)
• 401 (k) benefits with employer matching contribution

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level