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.

Responsibilities:

  • 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

Requirements:

  • 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.

Salary

$110K - $120K