Clinical Supply Associate (12 months fixed term / secondment)

ABOUT ASTRAZENECA

Every one of our employees makes a difference to patient lives every day. You may not feel you’re at the frontline of research but your role in changing patients’ lives is critical.  Our mission is ambitious, and it takes the skills of a collaborative team to really deliver on what science can do and to always put patients first. Working at AstraZeneca we believe in the potential of our people and our commitment to develop our people beyond what was thought possible.

The Clinical Supply Associate (CSA) works across various Clinical Manufacturing & Supply teams with task-based activities to ensure the delivery of clinical material and associated information to meet the agreed Clinical demand. The CSA follows SHE and GMP standards and is personally accountable for these areas within their own work plans. Once fully trained, experienced, and signed off in any GMP activity the individual is then able to carry out the GMP work associated with the role and can act as Trainer/Mentor.  The Clinical Supply Associate role covers parts of the clinical study lifespan, across all phases of the drug development lifecycle, covering small and large molecule drug products.

Job Responsibilities

In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this job title. Depending on which team the individual works in, the typical tasks may include any for the following:

• Manage Temperature Excursions

• Manage the Pack Order Process

• Manage Product Quality Complaints in the Events Quality Vault and sample returns

• Manage the Purchase Order process in the Coupa system to support projects, including interaction with external suppliers, and including coordinating delivery of some clinical materials through to GMP release

• Perform IRT User Acceptance Testing e.g., IRT systems, Smart Supplies and other Enterprise systems

• Perform eTMF management tasks and QC checks

• Facilitate/ lead/support Continuous Improvement activities

• Provision of metric data, etc.

• Work in collaboration with and support Clinical Supply Program Leads, Study Leads, Planners and External Study Managers

• Deviation facilitation/leadership

• Design, maintain and document business sub-processes, including creation of Standard Work Instructions and SOP updates

Typical Accountabilities

Safety, Health and Environment

• Contribute to improving SHE performance, proactively identifying SHE hazards and take appropriate actions

Compliance and Ethical Conduct

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.

• Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance

Delivery / Supply

• Ensuring customer service is always considered

• On time, in full (OTIF) delivery of goods and services from external suppliers to underpin successful delivery of CM&S projects

Cost

• Promoting a cost conscious environment to enable effective cost management

Lean & Agile Culture / Standardized ways of working

• Ensure all work is carried out in accordance to approved and established processes and procedures

What we offer:

Welcome to Warsaw Site, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day.

To help you maintain your best self, here’s a sneak peek into some of the things this site provides for you:

• The best team to support you,

• Multisport card,

• Pension plan,

• Life insurance,

• after-work events,

• private medical care

• lunch card,

• bright and spacious environment,

• sustainable office working environment.

Please note that we are working in a hybrid model of 3 days per week from the office in Warsaw