PQA Officer inDundee inDundee PUBLISHED 31 MAY 2024

Abbott


At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 196 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.


The Opportunity



Abbott Rapid Diagnostics (formerly Alere)
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 a
Product Quality Assurance Officer
.

In this role, you will be working as part of the Product Quality Assurance Team, with the primarily responsibility for the audit of manufacturing batch records, material inspection and approval at Abbott Dundee.

This is an individual contributor role with expectations aligned to the Capabilities and Behaviours as set out in the Abbott Dundee Employee Handbook.


What You’ll Do

• Compliance Audit of Manufacturing Records; Rare Reagent, Buffers, Bulk Formulation, Dispensing and Kit Pack.
• Compliance audit of QC test records.
• Material inspection versus specification; sub-assemblies, intermediates and finished kits.
• Material control within ERP System; approval, reject, rework, quarantine.
• Approve Quarantine removal and rework operations.
• Performing Archiving activities for Device History Records per record retention policy to maintain both on-site and off-site records archive.
• Working as part of a cross-functional team, attend and participate Tier Review Meetings within a Management Operating System, to facilitate the flow on material through the factory on a daily basis.
• Taking full accountability for personal workload, ensuring work is completed to a high standard in accordance with site policies, procedures and applicable regulations.
• Proactively contributing to continuous improvement initiatives and other general housekeeping duties.
• Taking a self-motivated approach to continuous professional development and engaging with site training initiatives.
• Developing excellent relations with the department team and wider Operations group.
• Proposing ideas for new opportunities to improve communication and productivity.
• Being aware of the policies as set out in the Abbott Employee Handbook.
• Carries out other duties as and when requested by Line and or Department Manager.
  
  

Required Qualifications & Skills

• SQA Qualification at Nat 5 level or equivalent in Maths, English and a science subject
• Relevant experience within a regulated industry
• Good attention to detail
• Excellent timekeeping and organisation skills
• Good communication skills, written and spoken
• Able to work flexibly and as part of a small team
• Experience with an Enterprise Resource Planning System (ERP) preferred
• Experience with Electronic Document Management Systems (EDMS) - preferred
• Proficient with MS Word, Excel and Power-Point.
• Awareness and understanding of record audit and material approval processes per ISO 13485:2for the Design and Manufacture of In-vitro Diagnostics preferred, training will be provided.
  
  

Working at Abbott


At Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And Family, Be Your True Self And Live a Full Life. You Will Have Access To

• Career development with an international company where you can grow the career you dream of.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
  
  

As you’d expect from an innovative global healthcare company, we offer an excellent starting salary, and a competitive range of benefits including a defined contribution pension scheme, and private healthcare.

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