Quality Control Specialist, Sterile (Nights)

Hims & Hers
Any Location, OH
Job Description
Hims & Hers is seeking an experienced Quality Control Specialist to join their Quality Unit in New Albany, Ohio. The role will focus on driving continuous improvement efforts and ensuring compliance with quality standards. The ideal candidate will have a B.S. in chemistry, microbiology, biology, quality management, engineering, or a related discipline, and 2+ years of experience in quality assurance/control, process/quality engineering, and/or product formulation.

Requirements

  • Perform in-process and post-production quality checks, including testing, assessing products in the compounding 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 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
  • Unlimited PTO
  • Company holidays
  • Quarterly mental health days
  • Comprehensive health benefits
  • Parental leave
  • Employee Stock Purchase Program
  • 401 (k) benefits with employer matching contribution
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