GMP Quality Control Chemist — Analytical Lab

Abbott Laboratories

Minnetonka (MN)

On-site

USD 61,000 - 123,000

Full time

3 days ago
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Benefits offered by this job

Health benefits
Retirement plan
Tuition reimbursement
Education benefits

Job summary

Abbott in Minnetonka, MN is seeking a Quality Control Chemist to support batch release and stability testing for drug-device products. You will perform analytical testing using HPLC, dissolution, GC, FTIR, UV-Vis and Karl Fischer to generate high-quality data in a GMP environment.

As part of the QC team, you will review results, prepare CoA and reports, maintain documentation, and collaborate with QA, Manufacturing, Regulatory Affairs, and R&D to ensure product quality and regulatory compliance.

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.

Responsibilities

  • 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-Vis spectroscopy, Karl Fischer titration, pH meters, Analytical balances, Microscopy, and related tools.
  • Evaluate analytical results against product specifications and acceptance criteria.
  • Generate testing summaries, CoA, and technical reports as required.
  • Maintain accurate, complete laboratory records in GMP and data integrity framework.
  • Document laboratory activities within LIMS and electronic notebooks.
  • Review laboratory data for accuracy and compliance with methods.

Skills

Attention to detail
Data integrity
Troubleshooting
Independent work
Communication
Organizational skills
Analytical thinking
Problem-solving
Team collaboration

Education

Bachelor’s degree in chemistry or related field

Tools

HPLC
GC
Dissolution apparatus
FTIR
UV-Vis
Karl Fischer titration
pH meters
Analytical balances
Microscopy
LIMS

Job description

Abbott in Minnetonka, MN is seeking a Quality Control Chemist to support batch release and stability testing for drug-device products. You will perform analytical testing using HPLC, dissolution, GC, FTIR, UV-Vis and Karl Fischer to generate high-quality data in a GMP environment.

As part of the QC team, you will review results, prepare CoA and reports, maintain documentation, and collaborate with QA, Manufacturing, Regulatory Affairs, and R&D to ensure product quality and regulatory compliance.

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