Quality Engineer III

United Pharma; New Jersey; On-site; USD 95,000 - 130,000; Full time

Job summary

United Pharma in New Jersey seeks an experienced Quality Engineer III to lead analytical method validation, verification, qualification, and transfer activities in a regulated setting. You will provide independent quality oversight, evaluate technical data, and drive continuous improvement across validation and quality processes.

The role requires strong knowledge of FDA regulations, GMP/GLP, ISO 13485, ICH guidelines, and 21 CFR Part 11, plus hands-on experience with analytical techniques and

Qualifications

• Extensive experience reviewing analytical method validation/transfer documentation.
• Strong knowledge of FDA regs, GMP, GLP, ICH guidelines, and ISO 13485.
• Experience with analytical validation parameters and statistical methods.
• Experience in a regulated pharmaceutical/biotech environment.

Responsibilities

• Review and approve analytical method validation, verification, qualification, and transfer protocols and reports.
• Evaluate validation parameters: accuracy, precision, specificity, linearity, range, robustness, and detection limits.
• Review statistical analyses and technical data for compliance with requirements.
• Support investigations, deviations, OOS/OOT, CAPA, and nonconformance activities related to analytical methods.
• Support design transfer and process validation by evaluating inspection, testing, and measurement methods.
• Ensure compliance with FDA regulations, GMP, ISO 13485, ICH guidelines, and 21 CFR Part 11 requirements.
• Collaborate with Quality Control, Manufacturing, R&D, Regulatory Affairs, and Engineering teams to resolve challenges.

Skills

FDA regulations knowledge

GMP/GLP/ISO 13485/ICH guidelines

Method validation expertise

Statistical analysis

Cross-functional collaboration

Education

Bachelor’s degree in Chemistry, Biochemistry, Biology, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or related

Tools

HPLC

Dissolution

Wet chemistry

Microbiological methods

Particulate testing

Job description

We are seeking an experienced Quality Engineer III to support analytical method validation, verification, qualification, and transfer activities within a regulated pharmaceutical, biotechnology, medical device, or combination product environment. The ideal candidate will provide independent quality oversight, evaluate technical data, ensure regulatory compliance, and drive continuous improvement across validation and quality processes.

Responsibilities:

• Review and approve analytical method validation, verification, qualification, and transfer protocols and reports.
• Evaluate analytical validation parameters, including accuracy, precision, specificity, linearity, range, robustness, and detection limits.
• Review statistical analyses and technical data to ensure scientifically sound conclusions and compliance with established requirements.
• Support investigations, deviations, OOS/OOT, CAPA, and nonconformance activities related to analytical methods and testing processes.
• Support design transfer and process validation by evaluating inspection, testing, and measurement methods.
• Ensure compliance with FDA regulations, GMP, ISO 13485, applicable ICH guidelines, and 21 CFR Part 11 requirements.
• Collaborate with Quality Control, Manufacturing, R&D, Regulatory Affairs, and Engineering teams to resolve technical challenges.

Skills and Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry, Biology, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or a related discipline.
• Minimum 7 years of experience in Quality, Analytical Development, Validation, Quality Control, or Quality Engineering within a regulated industry.
• Proven experience reviewing and approving analytical method validation, verification, and transfer documentation.
• Strong knowledge of FDA regulations, GMP, GLP, ISO 13485, ICH guidelines, and laboratory controls.
• Experience with analytical techniques such as HPLC, dissolution, wet chemistry, microbiological methods, or particulate testing.
• Strong understanding of statistical analysis and its application to method validation and process monitoring.