Inspection Quality Assurance Officer in Dundee

About Abbott: Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 110,000 colleagues serve people in more than 160 countries.

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. Our in‑vitro Diagnostic Assay manufacturing site in Dundee has an exciting opportunity for an Inspection Quality Assurance Officer to join the team.

MAIN PURPOSE OF JOB

Within the Product Quality Assurance environment, the Inspection Quality Assurance role is responsible for the incoming inspection, testing, and final disposition of all raw materials used in the manufacture of in‑vitro diagnostic tests at Abbott Dundee. This includes, but is not limited to, chemicals, biologicals, commodities, and printed matter. For critical chemicals and biologicals, the role includes creating and maintaining Statistical Process Control (SPC) charts to trend Critical Quality Attributes (CQAs), performing trend analysis, and reporting findings to the Product Quality Assurance Manager and Senior Biologics Manager.

MAIN RESPONSIBILITIES

• Verify compliance of incoming test records against specifications and make final disposition decisions.
• Ensuring all raw materials are inspected, tested and released to supply chain in a timely manner to support the Operations Master Schedule.
• Develop and maintain SPC charts of CQA’s of critical raw materials. Perform trend reviews and report findings to Product Quality Assurance Manager and Senior Biologics Manager.
• Develop and be accountable for key performance indicators (KPIs) for IQA function at operating management system meetings / tier meetings.
• Collaborate with the Product Quality Assurance Manager and key stakeholders (e.g., QC, Labelling, Stores) to plan and manage inspection/testing activities in alignment with the supply plan and departmental lead times.
• Plan and coordinate all aspects of personal workload for specified production job assignments.
• Perform Enterprise Resource Planning (ERP) transactions as part of works order and inventory management, including quarantine practices.
• Collaborate with the Quality Control Manager to plan and manage testing of chemicals and biologics to schedule, review results and determine material acceptability outcome.
• Collaborate with the Dispensing and Labelling Manager to plan and manage testing of first lot to stock of printed matter to schedule, review results and determine material acceptability outcome.
• Collaborate with peers to ensure on‑time delivery of the production schedule, meeting internal and external customer requirements and company quality standards.
• Liaise with outside contacts or vendors, as required.
• Complete and maintain and archive records as required by good manufacturing practice.
• Apply analytical thinking and expertise to identify root cause (RC) for technical issues that may arise and take responsibility to leading RC investigations, as required.
• Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by line/department/senior manager.

QUALIFICATIONS/EXPERIENCE

• Minimum BSc in Biochemistry or a related discipline to ensure sufficient technical knowledge for evaluating and approving critical raw materials.
• Computer literate with proficiency in Word, Excel, and PowerPoint for data analysis and presentation.
• Experience in completing quality documentation e.g. Manufacturing Batch Records, laboratory reports, and other quality records.
• Comprehensive understanding of inspection Quality Assurance processes and procedures.
• Previous experience of working in a laboratory or scientific role.
• Excellent written and oral communication skills.
• Understanding and application of Statistical Process Control (SPC) techniques.
• An appreciation for Enterprise Resource Planning (ERP) costs and how to influence them.
• Trained in Corrective and Preventive Action (CAPA) and Change Control principles, with the ability to process records in relevant systems.
• Skilled in Root Cause Analysis (RCA) tools, including A3 and DMAIC.
• Familiarity with Risk Assessment, Risk Management/Control, and Failure Mode Effect Analysis (FMEA).