Quality Control Chemist

The Opportunity

This position works out of our Minnetonka, MN location in the Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. Under the direction of department manager, the Quality Control Chemist may perform analytical testing in a GMP-regulated Quality Control laboratory supporting commercial combination drug-device products and stability programs. This role will execute batch release, stability, raw material, and investigational testing using a variety of analytical techniques including HPLC, dissolution, GC, FTIR, UV-Vis, and Karl Fischer. The successful candidate will be responsible for generating high-quality analytical data, maintaining compliant laboratory documentation, and supporting product quality through adherence to applicable GMP requirements, compendial methods, and internal procedures.

What You'll Work On

Analytical Testing

• Perform analytical testing to support batch release and stability programs for combination drug-device products.
• Conduct testing for drug-related attributes including assay, impurities, identification, content uniformity, drug release, dissolution, and related substances.
• Perform USP and EP compendial testing for raw materials, intermediates, and finished products.
• Prepare samples, standards, mobile phases, buffers, and reagents in accordance with approved analytical procedures.
• Operate analytical instrumentation including HPLC, GC, dissolution apparatus, FTIR, UV-Visible spectroscopy, Karl Fischer titration, pH meters, analytical balances, microscopy, and other laboratory instrumentation.

Data Review and Documentation

• Evaluate analytical results against product specifications and acceptance criteria.
• Generate testing summaries, Certificates of Analysis (CoA), and technical reports as required.
• Maintain accurate, complete, and contemporaneous laboratory records in compliance with GMP and data integrity requirements.
• Document laboratory activities within electronic laboratory notebooks and laboratory information management systems (LIMS).
• Review laboratory data for accuracy, completeness, and compliance with approved methods and procedures.

Quality Systems and Compliance

• Follow established quality system requirements, laboratory procedures, work instructions, and test methods.
• Support Out-of-Specification (OOS), Out-of-Trend (OOT), deviation, and laboratory investigation activities.
• Participate in laboratory audits, inspections, and continuous improvement initiatives.
• Ensure compliance with applicable GMP regulations, data integrity requirements, and company quality standards.
• Maintain awareness of current USP, EP, and ICH guidance relevant to Quality Control laboratory operations.

Laboratory Operations

• Perform routine instrument maintenance, calibration, and troubleshooting activities.
• Maintain laboratory cleanliness and organization in accordance with established procedures.
• Identify and resolve routine technical issues through scientific investigation and consultation with subject matter experts.
• Collaborate effectively with Quality Assurance, Manufacturing, Regulatory Affairs, Supply Chain, and R&D teams.