2923-1

Real Staffing Group; Town of Newark (WI); On-site; USD 60,000 - 85,000; Full time

Job summary

Real Staffing Group is seeking an Analytical Testing professional to join our quality team in Wisconsin. You will perform routine and non-routine analytical testing using HPLC, UPLC, and other chromatographic techniques to support product quality and regulatory compliance.

You will prepare samples, reagents, and mobile phases, review data for accuracy and integrity, and ensure 21 CFR Part 11 compliance while maintaining comprehensive documentation in cGMP environments.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or related discipline.
• 2-5 years of QC laboratory experience in a regulated industry.
• Hands-on experience performing HPLC analysis.
• Strong understanding of data integrity and 21 CFR Part 11 requirements.

Responsibilities

• Perform routine and non-routine analytical testing using HPLC, UPLC, and other chromatographic techniques.
• Prepare samples, standards, reagents, and mobile phases according to approved procedures.
• Conduct testing of raw materials, intermediates, finished products, stability samples, and cleaning validation samples.
• Analyze and interpret chromatographic data to ensure product quality and regulatory compliance.
• Troubleshoot analytical issues and investigate atypical or out-of-specification (OOS) results.

Skills

HPLC analysis

Data integrity understanding

Regulated industry experience

Education

Bachelor's degree in Chemistry/Biochemistry/Pharmaceutical Sciences/Biology

Tools

Empower software

Job description

company quality requirements.

Analytical Testing

• Perform routine and non-routine analytical testing using HPLC, UPLC, and other chromatographic techniques.
• Prepare samples, standards, reagents, and mobile phases according to approved procedures.
• Conduct testing of raw materials, intermediates, finished products, stability samples, and cleaning validation samples.
• Analyze and interpret chromatographic data to ensure product quality and regulatory compliance.
• Troubleshoot analytical issues and investigate atypical or out-of-specification (OOS) results.

System Operations

• Utilize Empower software for instrument control, data acquisition, data processing, and reporting.
• Review chromatographic data for accuracy, completeness, and compliance with data integrity requirements.
• Create, modify, and maintain Empower methods, processing methods, and report templates as required.
• Ensure electronic records comply with 21 CFR Part 11 requirements and company data integrity policies.

Documentation & Compliance

• Maintain accurate laboratory notebooks, worksheets, logbooks, and electronic records.
• Follow cGMP, GDP, and laboratory safety procedures.

Qualifications

• Bachelor\'s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or related discipline.
• 2-5 years of QC laboratory experience in a regulated industry.
• Hands-on experience performing HPLC analysis.
• Strong understanding of data integrity and 21 CFR Part 11 requirements.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

To find out more about Real, please visit www.realstaffing.com