Scientist – cGMP Quality Control Laboratory

Location: Eden Prairie, MN
Employment Type: Temporary/Contract
Contract Length: 3 months to start, with potential for extension or conversion to a permanent position
Pay Rate: $28–$34/hour, depending on experience
Department: Analytical Laboratory
Reports To: Laboratory Manager

Scientist – cGMP Quality Control Laboratory

Kelly® Science & Clinical is seeking a Scientist for a contract opportunity with a regulated laboratory in Eden Prairie, MN. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Position Summary

We are seeking a detail-oriented Scientist to support an FDA-registered cGMP Quality Control laboratory performing analytical testing for pharmaceutical and other regulated clients.

In this role, you will perform routine and non-routine sample analysis using techniques including UV/Visible spectroscopy, filtration, and microscopy. The ideal candidate will bring 2–3 years of hands-on experience in a cGMP-regulated laboratory along with a strong understanding of data integrity, Good Documentation Practices (GDP), and regulatory compliance.

Key Responsibilities

• Perform routine and non-routine analytical testing of client products according to approved SOPs, test methods, and specifications.

  
  

• Conduct UV/Visible spectrophotometric analysis, including sample preparation, instrument calibration, testing, data analysis, and interpretation.

  
  

• Execute filtration procedures, including membrane filtration and particulate testing, and evaluate filter integrity and performance.

  
  

• Perform light/optical microscopy, including sample preparation, microscopic examination, particle or contaminant identification, and image documentation.

  
  

• Accurately document test results in laboratory notebooks, LIMS, and/or electronic systems in accordance with cGMP, GDP, and data integrity requirements.

  
  

• Review laboratory data for completeness, accuracy, and compliance with approved methods prior to secondary review and reporting.

  
  

• Maintain, calibrate, and troubleshoot laboratory instrumentation and coordinate preventive maintenance and calibration activities as needed.

  
  

• Prepare and standardize reagents, solutions, and reference standards used in laboratory testing.

  
  

• Investigate out-of-specification (OOS), out-of-trend (OOT), deviations, and atypical results, supporting root cause analysis and CAPA activities.

  
  

• Support the creation, revision, and periodic review of SOPs, worksheets, forms, and analytical test methods.

  
  

• Maintain compliance with applicable cGMP, GLP, FDA, USP, ICH, safety, and regulatory requirements.

  
  

• Support internal, customer, and regulatory audits by providing laboratory documentation and technical explanations as needed.

  
  

• Maintain a clean, organized, and safe laboratory environment, including appropriate handling and disposal of chemicals and biological materials.

Required Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Materials Science, or a related scientific discipline, or an equivalent combination of education and relevant experience.

  
  

• 2–3 years of laboratory experience in a cGMP-regulated environment, such as pharmaceutical, biotechnology, medical device, or a related regulated industry.

  
  

• Hands-on experience with UV/Vis spectroscopy, including instrumentation, sample preparation, and data analysis.

  
  

• Practical experience with filtration techniques, such as membrane filtration, filter integrity, and/or particulate testing.

  
  

• Experience with light/optical microscopy, including sample preparation and image documentation.

  
  

• Working knowledge of cGMP, Good Documentation Practices (GDP), and data integrity requirements.

  
  

• Strong written and verbal communication skills with the ability to clearly and accurately document technical work.

  
  

• Excellent attention to detail, organization, and ability to manage multiple priorities in a fast-paced laboratory environment.

  
  

• Proficiency with Microsoft Office; experience with LIMS or electronic laboratory notebooks (ELN) is a plus.

Preferred Qualifications

• Experience supporting analytical method validation, method verification, or technology transfer.

  
  

• Familiarity with USP, EP, ICH, and FDA regulatory expectations.

  
  

• Previous experience authoring, supporting, or executing deviation, OOS, OOT, or CAPA investigations.

Position Details

This is a temporary 3-month contract position with the potential to be extended or converted to a permanent opportunity based on business needs and performance.

Target Pay: $28–$34/hour, based on qualifications and experience.

What Happens Next

Once you apply, you’ll proceed to the next steps if your skills and experience appear to be a strong match for the position. Even if this opportunity isn’t the right fit, joining the Kelly® talent network can help connect you with future science and clinical opportunities.

Apply today and take the next step in your scientific career with Kelly® Science & Clinical.

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