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Quality Control Specialist, Sterile (Nights)

Hims & Hers· QUALITY
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New Albany, OhioFull-timePosted 4d ago

About the role

Quality Control Specialist to join the Quality Unit in New Albany, Ohio. Focus on in-process and post-production quality checks, investigation support, and adherence to QA policies, USP, SOPs, and cGMP. Night shift role.

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.

Qualifications

  • B.S. in chemistry, microbiology, biology, quality management, engineering, or related discipline preferred
  • 2+ years of experience in 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 (costs covered)
  • 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 <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 multitask 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

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
Last updated Oct 21, 2026. Interested? Apply on the company site.

About Hims & Hers

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