New · posted Nov 12
Abbott · Medical Devices
Quality Control Chemist
- Minnetonka, MN
- On-site
- Full-time
- Associate & Specialist
The role
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. The position offers the opportunity to work in a collaborative, science-driven environment supporting commercially marketed combination products.
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.
Working at Abbott
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:
- 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.
What you need
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 analysis.
- Experience performing dissolution testing.
- Experience supporting pharmaceutical, drug-device combination product, or other regulated product testing programs.
- Strong laboratory documentation and technical writing skills.
- Working knowledge of GMP requirements and data integrity principles.
- Proficiency with Microsoft 365 applications.
- Strong analytical thinking, troubleshooting, and problem-solving skills.
- Ability to work independently while managing multiple priorities in a fast-paced environment.
- Strong verbal and written communication skills.
Preferred Qualificationsnice to have
- 3+ years of Quality Control laboratory experience in the pharmaceutical or combination product industry.
- Experience performing batch release and stability testing.
- Working knowledge of USP and EP compendial methods.
- Familiarity with ICH quality guidelines and regulatory requirements.
- Experience participating in OOS, OOT, deviation, and laboratory investigations.
- Experience with method verification, method transfer, or method validation activities.
- Experience with LabVantage LIMS or comparable laboratory information management systems.
- Experience with FTIR, GC, Karl Fischer titration, and related analytical techniques.
- Experience supporting combination drug-device products including USP Apparatus 7.
Key Competencies
- Attention to detail and commitment to data quality.
- Technical curiosity and scientific problem-solving.
- Strong organizational and time management skills.
- Effective communication and collaboration.
- Commitment to GMP compliance and patient safety.
- Ability to learn new analytical methods and technologies.
- Continuous improvement mindset.
What you'll do
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.
Pay and benefits
$61,300 – $122,700 a year
Employer providedThe base pay for this position is
$61,300.00 – $122,700.00
In specific locations, the pay range may vary from the range posted.
Free medical coverage option (HIP PPO plan)
Retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit
Career development
Where you'll work
Minnetonka, MNOn-siteOpen in Maps (opens in a new tab)
More jobs in Minnetonka, MNWorking conditions
Standard
TRAVEL
Yes, 10 % of the Time
MEDICAL SURVEILLANCE
Not Applicable
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
JOB FAMILY
Research and Discovery
DIVISION
AVD Vascular
LOCATION
United States > Minnesota > Minnetonka : 14900 Minnetonka Industrial Road
Equal opportunity, accessibility and legal noticesAbbott's statements, word for word
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Job intelligence
The context around this role
Live data · November 12, 2026
Salary intelligence
How the pay compares
This role's midpoint is 26% above the US median for Quality Control roles at this level.
This roleEmployer provided
Associate & Specialist roles in Minnesota5 roles publishing pay
Associate & Specialist roles in the US90 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $61,300 | — | $122,700 |
| Minnesota (middle half) | $50,000 | $56,000 | $62,000 |
| All US (middle half) | $63,625 | $72,750 | $88,250 |
This role: Abbott's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 264 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Abbott's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 56 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods32
- Documentation and SOPs9
- GMP and compliance8
- Data and digital systems5
- Collaboration and leadership5
- Investigations and CAPA4
- Quality systems and risk3
- Validation and qualification1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Control work in medical devices, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- FDA21 CFR Part 4(official source, opens in a new tab)Current good manufacturing practice for combination productsNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- ISOISO 11737-1(official source, opens in a new tab)Determination of the microbial population (bioburden) on medical devices
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
Company hiring pulse
Abbott on Regulatory Jobs
- 118
- Open roles
- 118
- Distinct roles
- 34
- Locations
By discipline
- Quality63 53%
- Regulatory30 25%
- Clinical25 21%
By level
- Senior & Principal57 48%
- Associate & Specialist34 29%
- Manager25 21%
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Quality Control Chemist at Abbott
Open until filled. $61K–$123K a year, employer provided.