QC Analyst

at  Abbott Laboratories

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.

REQUIRED QUALIFICATIONS / PROFILE

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

As a QC Analyst, you will be responsible for the independent testing of raw materials, process intermediates and finished product, versus predefined acceptance specifications. More specifically:

• Documenting test results in accordance with cGMP/cGDPs
• Using statistical process control of raw material, process intermediates and finished product performance to ensure lot to lot consistency.
• Perform on-market stability and performance testing including participation in analyte proficiency schemes (where required).
• Represent Product Quality Control within audit.

Working hours: Monday-Friday shift pattern (2 weeks early shift/2 weeks late shift)