Quality Assurance Manager


Hicksville, NY

Industry: Business Services


8 - 10 years

Posted 37 days ago

Job Summary

Title: Quality Assurance Manager

Company: Pharmaceutical

Type: Permanent Role

Notes: No Corp to Corp

Manages and coordinates majority of the QA department and duties within. Responsible for overseeing and ensuring, quality policy and regulatory obligations, are implemented and followed company wide.


  • Responsible for activities within the QA Department and quality of the firm-company wide
  • Head of Quality Management Review Team
  • Author validation & manufacturing protocols, including Installation Qualification, Operational Qualification, and Performance Qualification
  • Review Standard Test procedures (STPs)
  • Initiate SOPs, companywide and distribute
  • Review SOPs and revise accordingly
  • Maintain all Quality Assurance and Quality Control master files
  • Review all chemistry notebook, including calculations, if required
  • Prepare for and represent firm for all certifications and reassessments
  • Update Quality manual
  • Prepare and carry out validation activities as required
  • Perform internal and vendor audits.
  • Determining in-house quality procedures, standards and specifications
  • Setting customer service standards
  • Specifying quality requirements and agreements of raw materials with suppliers
  • Investigating and setting standards for quality and health and safety
  • Ensuring that manufacturing processes comply with standards at both national and international level
  • Working with operating staff to establish procedures, standards, systems
  • Writing management and technical reports
  • Determining training needs
  • Recording, analyzing, distributing and archiving statistical information
  • Monitoring performance
  • Supervising technical or laboratory staff


  • BS degree required
  • cGMPs, Part 11 compliance, ISO 13485:2016, Capa's, Agency Audits, Internal / external cGMPs, GLP, CFR, Metrology SOP/STP, Turbochrome, HPLC, PerkinElmer
  • FDA regulations and audits
  • Health Canada, MDSAP program knowledge a plus.


$110K - $120K