QC Analyst I

JOB DESCRIPTION:

• 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

• 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

• Degree or equivalent preferably a life science subject area and/or

• Experience in a regulated industry preferred

• 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.

The base pay for this position is

In specific locations the pay range may vary from the range posted.

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