Job Description

Job Title: Quality Assurance Manager
Job Location: New York


  • Approves all written responses as required for customer communications
  • Reviews, approves and distributes raw material, packaging, and finished product specifications
  • Authorizes all facility changes following site change management processes
  • Leads the effort for investigations through root cause analysis towards the development of corrective and preventive actions
  • Performs customer specification reviews against standard product offering and process capability
  • Develops stability data for existing products and new commercializations, including data to support packaging changes
  • Approves the artwork and master copy for the labeling of all new and existing products
  • Ensures the Plant systems, master documents, product documentation, and products comply with the relevant company, customer, and regulatory cGMP requirements
  • Provides feedback to Production on the quality of products produced through the issuance of Quality Alerts and Discrepancy reports
  • Works with Production, Logistics, and Product Development on new product transfer
  • Responsible for the Food Defense and Crisis Management Plan
  • Responsible for ensuring and promoting operational safety, environmental protection, and employee health/industrial hygiene within all departments to comply with federal, state, local, and company rules and regulations
  • Responsible for providing monthly facility training on relevant quality topics
  • Responsible for interviewing, selecting, training, evaluating, and disciplining employees
  • Responsible for advancing the development of employees for the succession plan
  • Lead a team of quality assurance and quality control leaders to ensure products are manufactured according to policy and in compliance with regulations and customer requirements
  • Development and execution against a defined quality improvement plan organized by priority
Required Qualifications:
  • Bachelor of Science degree in science related field
  • Five+ years practical experience in pharmaceuticals, excipient, cosmetic, or dietary supplement quality assurance
  • Five+ years managerial experience within functional areas in quality assurance
  • Working knowledge of GMP, Microbiology, GLP, Hygiene controls, Validation and HACCP principals
  • Competencies in IT based applications such as LIMS, SAP etc.
  • Ability to evaluate pharmaceutical ingredient manufacturing against established regulations
  • Effectively train essential plant employees in excipient principles and ISO initiatives
  • Drive continuous improvement
  • Affect change through direct and indirect leadership
  • Write SOPs and work instructions
  • Effectively work with production team and other members of quality team to develop and maintain a robust and effective quality management system
  • Possess excellent written and verbal skills and be proficient at Word, Excel, PowerPoint

Preferred Qualifications:

  • Experience in the food industry along with pharmaceuticals

QBH#: 2136

Application Instructions

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