QC Stability Specialist (12 month fixed term contract)

Position Summary

QC Specialist-Stability and Retain Management is responsible for maintaining the Stability and Retain Programmes for all products at ADMF and ensures that all activities are fully in compliance with cGMP standards, regulatory commitments and Alexion Standards and Protocols. The QC Specialist-Stability and Retains is responsible for performing key quality tasks.

Principal Responsibilities

• Management of stability and retain inventory (DS, DP and Device) for all commercial and relevant clinical products stored at ADMF.

• Ensuring that stability pulls are conducted on time, in adherence with ADMF level-loading principles and that samples are distributed to ADMF labs within agreed timelines.

• Scheduling of stability pulls and reporting of metrics for pull adherence via Stability Review Board.

• Ensuring that annual retain inspections are conducted on time.

• Authoring Stability Study Documents.

• Enrolling lots into stability and retain studies in LIMS, according to protocols and in partnership with the Stability and QC Sample Management Teams.

• Change management activities in accordance with Alexion procedures.

• Act as stability and retain management SME for Health Authority inspections.

• Identify and implement continuous improvement programs as appropriate.

• Mentoring and training of colleagues, as required.

• Shipment of stability and retain samples, as applicable, for external testing.

• Processing additional sample requests.

• Leading and owning Laboratory Investigations and Deviations relating to management of stability and retain programmes and sample management.

• Support QC Sample Management activities according to business needs (e.g. aliquoting support, sample distribution, shipments).

Qualifications

• Excellent communication, interpersonal and organizational skills.

• Ability to work well both independently and in a team environment with minimal supervision.

• Ability to prioritize work, multitask and escalate as appropriate.

• Conducts work in compliance with cGMPs, ICH guidelines and safety and regulatory requirements.

• Takes a structured, analytical approach to problem solving.

Education

• Degree in chemistry or biological science with a minimum of 5 years experience in the Pharmaceutical/Biotechnology Industry.

• Computer skills (MS Office, MS Excel, MS Project) or comparable word-processing and spreadsheet applications is required.

• Experience in the use of Electronic Document Management and Quality Management Systems is an advantage.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.