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