Quality Control Chemist

Abbott (abbottcareers2 board); United States; On-site; USD 70,000 - 100,000; Full time

Job summary

Abbott in Minnetonka, MN, seeks a Quality Control Chemist to support analytical testing for commercial products in a GMP-regulated laboratory. The role involves batch release, stability, raw material, and investigational testing using HPLC, GC, FTIR, UV-Vis, and other techniques.

The successful candidate will generate high-quality data, maintain compliant documentation, and ensure adherence to GMP, USP/EP guidance, and internal procedures while collaborating across QA, Manufacturing, Regulatory,

Qualifications

• Bachelor's degree in chemistry or closely related field.
• Minimum of 2 years of experience in a GMP-regulated analytical laboratory.
• Hands-on experience performing HPLC/UPLC analyses.

Responsibilities

• Perform analytical testing to support batch release and stability programs for combination drug-device products.
• Evaluate analytical results against product specifications and acceptance criteria.
• Generate Certificates of Analysis, testing summaries, and technical reports.
• Maintain accurate laboratory records in compliance with GMP and data integrity standards.
• Collaborate with QA, Manufacturing, Regulatory Affairs, and R&D teams.

Skills

HPLC/UPLC analysis

GMP compliance

Analytical testing

Education

Bachelor's degree in Chemistry / Analytical Chemistry / Pharmaceutical Sciences

Tools

HPLC

UPLC

GC

Dissolution

FTIR

UV-Vis

Karl Fischer titration

pH meters

Analytical balances

Job description

JOB DESCRIPTION

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 122,000 colleagues serve people in more than 160 countries.

Quality Control Chemist

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Minnetonka, MN location in the CRM division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats. 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. The position offers the opportunity to work in a collaborative, science-driven environment supporting commercially marketed combination products.

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 Fisher 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.

Required Qualifications

• Bachelor's degree in chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related scientific discipline.
• Minimum of 2 years of experience in a GMP-regulated analytical laboratory.
• Hands-on experience performing HPLC/UPLC analysi