Quality Assurance Officer
Fisher Clinical Services
Auckland, New Zealand
18h ago

About Thermo Fisher Scientific NZ

Over 250 employees bring a wide variety of skills and expertise to deliver world-class science products and solutions. Our manufacturing and distribution sites in Auckland and Christchurch (and satellite sites scattered across the country) cover a vast product portfolio, including lab equipment and chemicals, life sciences, diagnostics, microbiology and analytical instruments.

  • We deliver science solutions to a wide range of key markets such as academia and research; diagnostics and healthcare; environmental;
  • food, dairy and beverage; industrial process; life sciences; pharmaceutical and biopharmaceutical.

    Quality Assurance Officer

    Reports to : Quality Assurance Supervisor

    Position Location : Penrose

    Number of Direct Reports : None

    How you'll make an impact :

    You'll be part of a friendly and dynamic team that supports our customers in the development of life changing drugs & vaccines.

    In this role you will be responsible for facilitating and reviewing the quality control documentation, reviewing batch manufacturing records and other activities to maintain and operate the quality system.

    This is a hands on role to complete the day to day quality assurance (and quality control tasks as applicable) in conformance with cGMP / ISO principles.

    What will you do?

  • Facilitate quality system documentation (SOP’s, Standard Forms, BMRs, etc), including writing, reviewing and issuing documents
  • Review batch manufacturing records and documentation and release product, chemicals and components.
  • Review, process and approve deviations, non-conforming product and corrective actions
  • Proactive approach to maintenance of the QMS
  • Lead and complete internal audits according to the audit program
  • Train others in quality systems and documentation, articulate and advance QA principles at shop floor level
  • Champion and participate effectively in process improvement teams and complete any assigned actions.
  • Complete other activities that support maintaining and operating the Quality System.
  • Observe all safety rules which are established to maintain safe work practices, including wearing personal protective equipment (PPE).
  • Conduct proactive hazard identification and report any accidents, incidents and near misses

    How will you get here?

  • Tertiary Science qualification
  • Knowledge of quality control laboratory methods, quality assurance methods, and regularly compliance standards including ISO9001 and general cGMP requirements
  • Computer literate in word processing, spreadsheets, database applications
  • Experience with regulatory affairs (MPI preferable)
  • What will put you ahead of the competition?

  • Attention to detail
  • Disciplined, thorough, methodical, systematic
  • Highly self-directed and pro-active
  • Excellent communication skills
  • Computer literate in word processing, spreadsheets and preferably an integrated manufacturing program
  • Proven track record implementing continuous improvement and change
  • Proven team building and team participation skills
  • Adaptable and flexible to changing customer demands and requirements
  • What’s in it for you?

  • Work in a collegial, customer focussed and motivated team
  • Work within a strong culture of process improvement and lots of great tools
  • Access to global systems training and professional colleagues
  • Embedded quality system
  • Ongoing learning and development opportunities on the job and through our own on-line Thermo Fisher University
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