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 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.
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 Qualifications
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.
Apply Now
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- The base pay for this position is
- $61,300.00 – $122,700.00
- In specific locations, the pay range may vary from the range posted.
JOB FAMILY
Research and Discovery
DIVISION
AVD Vascular
LOCATION
United States > Minnesota > Minnetonka : 14900 Minnetonka Industrial Road
ADDITIONAL LOCATIONS
WORK SHIFT
Standard
TRAVEL
Yes, 10 % of the Time
MEDICAL SURVEILLANCE
Not Applicable
SIGNIFICANT WORK ACTIVITIES
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.pdf
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