Quality Assurance Associate, Bulk And Recombinant Value Stream

vor 2 Monaten


Melbourne, Österreich Csl Behring Vollzeit

Your Role The Quality Assurance (QA) Associate, Bulk and Recombinant Value Stream assures the appropriate quality of systems and processes adherence to applicable CSL standards and procedures.
In this role you will review and approve records, support quality risk assessments, non-conformances, investigations, CAPAs, and change controls in addition to monitoring and continuous improvement of quality performance metrics.
Your Responsibilities Reporting to the Manager, Quality Assurance you will:
Be responsible for product quality and compliance, partnering with all teams within the site value streams regarding product quality aspects. Oversee all production and support related activities to provide real time (GEMBA) and post event (CCIT) review of process steps, media filling and visual inspection oversight, documentation, activities and behaviour. Complete in-process checks, sampling and inspection for AQL processes. Provide quality guidance and point of contact for escalations. Perform QA review and approval of operational, processing and records to ensure regulatory compliance with Australian, EU and USA regulatory requirements, as defined in relevant CSL procedures. Provide technical input to the process of deviation/events in addition to root cause analysis, development and agreement of robust CAPAs. Assessment and escalation of identified issues to ensure review is completed to meet batch release timelines. Your Experience A minimum of a Bachelor Degree in Science, Engineering, Biotechnology, Biological Sciences, Pharmaceutical science or equivalent qualification or experience. At least three (3) years working in a similar role. Experience in Operational pharmaceutical manufacturing, technical support and manufacturing, Pharmaceutical Quality and compliance. Capable of making quality decisions, with coaching from peers, based on risk and provide sound advice and justification. Proficient in the use of the Microsoft Office suite including Outlook, Word, Visio and Excel and electronic document management systems (eDMSs). Strong interpersonal, organisational and analytical skills and able to negotiate outcomes with multiple stakeholders. Demonstrated ability to problem solve by applying advanced technical knowledge and experience. To apply, submit your CV no later than Friday 22nd November 2024.


#J-18808-Ljbffr



  • Melbourne, Österreich Healthcare Professionals Group Vollzeit

    BenefitsBe part of a supportive and stable working environmentWorking within a global teamAbout the companyWork within a large global Biotechnology company that boasts a good company culture that is always expanding.About the opportunityThe Quality Assurance Associate will be responsible for all activities involving quality assurance and compliance...


  • Melbourne, Österreich Baxter Laboratories Vollzeit

    Baxter Laboratories is a privately owned Australian company located in Boronia, specializing in the development and manufacturing of skincare, sunscreen, and topical pharmaceutical/dermatological products.Established in 1994, Baxter Laboratories has grown quickly to become a market leader in innovative, high-quality products.Products manufactured by Baxter...


  • Melbourne, Österreich Buscojobs Vollzeit

    Rare opportunity to join our QA team.If you are currently working for a CRO or Pharma organisation in QA then we'd love to hear from you.Who are we? We're Avance Clinical, an Australian based Contract Research Organisation.We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry.Why should you join Avance...


  • Melbourne, Österreich Avance Clinical Pty Vollzeit

    Rare opportunity to join our QA team.If you are currently working for a CRO or Pharma organisation in QA then we'd love to hear from you.Who are we?We're Avance Clinical, an Australian-based Contract Research Organisation.We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry.Why should you join Avance...

  • Quality Assurance

    vor 2 Monaten


    Melbourne, Österreich Sobi Group Vollzeit

    Quality Assurance & Compliance Associate Full-time Sobi Location: Australia Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them.Our employees come from a variety of backgrounds within research,...


  • Melbourne, Österreich Directionshealth Vollzeit

    Quality Assurance and Innovation CoordinatorEmployment Services (Community Services & Development)Full timeJoin a dynamic Not for Profit Charity Ranked 8th (Australia and New Zealand) in the Australian Financial Review Most Innovative Companies – NFP, Government and Education sectors, of more than 1,000 candidates.FSA is at an exciting time in its...


  • Melbourne, Österreich Buscojobs Vollzeit

    Link Healthcare, a Clinigen company, is a growing specialty pharmaceutical services company, with one clear aim: to accelerate access to medicines for people around the world.To achieve our aim, we work with a global pharma, biotech, and a network of suppliers, to source hard-to-get medicines, navigate complex regulatory environments, and provide access to...


  • Melbourne, Österreich Buscojobs Vollzeit

    This is a rare opportunity to join our high performing QA team.If you are currently working for a CRO or Pharma organisation in QA then we'd love to hear from you.Who are we? We're Avance Clinical, an Australian based Contract Research Organisation.We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry.Why...


  • Melbourne, Österreich Australia And New Zealand Banking Group Limited Vollzeit

    Select how often (in days) to receive an alert:Assurance and Well Managed AssociateDepartment: Business Governance & AssuranceDivision: Australia CommercialLocation: MelbourneAbout UsAt ANZ, we're shaping a world where people and communities thrive, driven by a common goal: to improve the financial wellbeing and sustainability of our millions of...


  • Melbourne, Österreich Australia And New Zealand Banking Group Limited Vollzeit

    Select how often (in days) to receive an alert:Assurance and Well Managed AssociateDepartment: Business Governance & AssuranceDivision: Australia CommercialLocation: MelbourneAbout UsAt ANZ, we're shaping a world where people and communities thrive, driven by a common goal: to improve the financial wellbeing and sustainability of our millions of...


  • Melbourne, Österreich Quality Enterprises Usa Vollzeit

    The Company How would you like to work with a multiple award-winningInternationalmanufacturing company with offices around the world?tnaare an innovative and successful integrated packaging & processing solutions company with over 14,000 system installed across 120+ countries.tna design and manufacture high-speed packaging, distribution & processing...


  • Melbourne, Österreich Hanes Brands Inc Vollzeit

    Quality Assurance Manager | Apparel | Kew | Melbourne - Inner (VIC)14-Nov-2024Category: RetailPosition Type: Permanent Full-TimeApplication Close Date: 14-Dec-2024Job DescriptionHybrid and flexible working, health & wellbeing programs.Collaborative culture with a genuine commitment to sustainability.Huge focus on learn and grow opportunities. Quality...


  • Melbourne, Österreich Mygwork Vollzeit

    This job is with Danaher, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly. Leica Biosystems' mission of "Advancing Cancer Diagnostics, Improving Lives" is at the heart of our corporate culture.We're a global leader in cancer diagnostics with the most...


  • Melbourne, Österreich Tideri Jobbörse Vollzeit

    BenefitsBe part of a supportive and stable working environment Working within a global team About the companyWork within a large global Biotechnology company that boasts a good company culture that is always expanding.About the opportunityThe Quality Assurance Associate will be responsible for all activities involving quality assurance and compliance...


  • Melbourne, Österreich Csl Behring Vollzeit

    The Opportunity:We are looking for a Manager- Sterility Assurance to join our Sterility Assurance team at CSL Behring. In this pivotal role, you will prioritise, organize, and communicate workload and issues/resolutions through appropriate forums and representing topics on local levels. You will work in close collaboration with the local function, most...


  • Melbourne, Österreich Csl - Australia Vollzeit

    The Opportunity: We are looking for a Manager- Sterility Assurance to join our Sterility Assurance team at CSL Behring.In this pivotal role, you will prioritise, organize, and communicate workload and issues/resolutions through appropriate forums and representing topics on local levels.You will work in close collaboration with the local function, most...


  • Melbourne, Österreich Service Stream Vollzeit

    time left to apply End Date: December 16, 2024 (21 days left to apply) job requisition id JR-114222 Primary Location VIC - Williamstown Job Description Summary Support us with Intelligent Transport Systems (ITS) projects across Victoria. About the Role We are looking for an ITS Program Manager to join our team to manage the planned maintenance and capital...


  • Melbourne, Österreich Csl Plasma Inc. Vollzeit

    Manager- Sterility AssuranceApply locations: APAC, AU, Broadmeadows, CSL BehringTime type: Full timePosted on: Posted 2 Days AgoTime left to apply: End Date: December 7, 2024 (13 days left to apply)Job requisition id: R-247115The Opportunity: We are looking for a Manager- Sterility Assurance to join our Sterility Assurance team at CSL Behring.In this pivotal...


  • Melbourne, Österreich Tideri Jobbörse Vollzeit

    Quality Assurance Manager Apparel Kew Melbourne - Inner (VIC) Category: Retail Position Type: Permanent Full-Time Application Close Date: 14-Dec-2024 Job Description We are looking for an experienced Quality Assurance Manager to join the Apparel Group.Managing a team of QA Coordinators across Sydney and Melbourne, you will be responsible for leading all...


  • Melbourne, Österreich Country Road Group Vollzeit

    We seek only the best candidates who are passionate brand ambassadors and determined to contribute to our team's performance. We are always on the look-out for dedicated, fashion-forward and like-minded individuals!Country Road Group (CRG) is embarking on transformation to position itself for growth, leveraging our scale, capabilities and culture as a House...