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Director of Quality Assurance

Located about 35 miles east of NYC we are a team of talented employees with an obsession towards QUALITY manufacturing various types of OTC Care, Personal Care & Home Care Products and associated chemicals.

The Director of Quality Assurance oversees the Production and Receiving Inspection Quality Program.

 

Job Description

  • Maintain Receiving Inspection (QARI) and In-Process Inspection (QAPI) programs in accordance with FDA 21 CFR Part 211 and British Retail Consortium requirements.
  • Develop, establish and validate routine in-process testing methods and procedures.
  • Manages the incoming inspection, in-process inspection, lot code management, production quality and supplier quality programs.
  • Manage resources to properly support workload.
  • Determines resource requirements, schedules, and procedures to properly monitor ongoing operations.
  • Review and approve reports and procedures.
  • Facilitate nonconforming product, OOS investigations, and CAPA investigations.
  • Maintain in-process and receiving inspection test equipment calibration program.
  • Facilitate manufacturing and engineering in establishing and verifying critical process parameters.
  • Maintain the change control program together with product life cycle management.
  • Provide trend and other management reports to company executives.
  • Coordinates and facilitates non-conformance investigations, and notifies management of issues that can impact safety, effectiveness or customer satisfaction in a timely ¬∑manner.
  • Work with Production and Engineering Management to establish and verify critical process parameters for process control of compounding, production and packaging operations.
  • Facilitate product life cycle management in evaluating changes to the manufacturing process and product.

Qualifications

  • Bachelor Degree in Chemistry or a Life Science with Chemistry Background.
  • Lean-six sigma background or certification is preferable.
  • Five (5) years’ experience in quality assurance/quality engineering in the pharmaceutical or medical device industry preferred.
  • Five (5) years’ experience with pharmaceutical or medical device quality management.
  • Knowledge of FDA 21 CFR211, 21 CFR820, ISO and related guidance documents.
  • Knowledge of Statistical Sampling Plans and Methods including ANSIIASQ Z1.4, ANSI/ASQ Z1 .9 and the One Proportion Test.
  • Knowledge of Statistical Process Control Methods including process capability and control charting.
  • Project management skills.
  • ERP and EQA Programs, Minitab, Microsoft Excel, Word, Power Point, and Adobe Acrobat