QC Analyst I
Abbott
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 serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
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 a QC Analyst I to join the team.
MAIN PURPOSE OF JOB
This is an individual contributor role with expectations aligned to the Capabilities and Behaviours as set out in the Abbott Dundee Employee Handbook.
Working as part of the Product Quality Control Team, the Analyst, Product Quality Control is primarily responsible for the independent testing of raw materials, process intermediates and finished product, versus predefined acceptance specifications, to defined timelines
ACCOUNTABILITIES
Independent testing of raw material, process intermediate and finished product testing versus predefined acceptance specifications using a range of analytical techniques including Immuno assay, Clinical Chemistries and Chromatography.
Documenting test results in accordance with cGMP/cGDPs
Perform on-market stability and performance testing including participation in analyte proficiency schemes (where required).
Participate in Leader Standard Work within a Management Operating System; Tier 1 - 2, Team/Department Briefings.
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.
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
BASE REQUIREMENTS
Degree or equivalent, preferably a life science subject area, and/or
Experience in a regulated industry preferred
BACKGROUND
Experience within the life sciences or similarly regulated industry (In-vitro Diagnostics preferred)
A practical understanding of immunoassay and clinical chemistry testing, In-vitro Diagnostics (preferred)
An ability to employ state-of-the-art Root Cause Analysis (RCA) tools, including A3/DMAIC (preferred)
The capability to contribute to and perform Risk Assessments, Risk Management/Control exercises, and Failure Mode Effect Analyses (FMEA).
An understanding of and ability to apply Statistical Process Control (SPC) techniques.
Experience with an Enterprise Resource Planning System (ERP)
Experience with Electronic Document Management Systems (EDMS)
Proficient with MS Word, Excel and Power-Point.