Quality Assurance Engineer

Stark Pharma Solutions Inc; Indianapolis (IN); On-site; USD 80,000 - 110,000; Full time

Job summary

Stark Pharma Solutions Inc in Indiana is seeking a Quality Assurance Engineer with strong experience in regulated manufacturing environments to support quality systems, compliance, documentation, and continuous quality improvements.

You will collaborate with Manufacturing, Engineering, Quality Control, and Regulatory teams to ensure GMP, FDA, and ISO compliance, maintain quality records, and drive CAPA and deviation investigations.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 3+ years of experience in Quality Assurance within a pharmaceutical, medical device, biotech, or regulated manufacturing environment.
• Experience with GMP and quality systems.
• Knowledge of deviations, CAPA, change controls, and root-cause analysis.
• Experience With Quality Documentation And Compliance Requirements.
• Strong analytical, documentation, communication, and problem-solving skills.
• Ability to work effectively with cross-functional teams.

Responsibilities

• Support quality assurance activities and maintain quality system documentation.
• Review and maintain quality records, procedures, and manufacturing documentation.
• Support deviations, CAPA, change controls, and root-cause investigations.
• Assist with internal and external quality audits.
• Work with Manufacturing, Engineering, Quality Control, and Regulatory teams to resolve quality issues.
• Ensure processes and documentation comply with GMP, FDA, and ISO requirements.
• Support continuous improvement and quality compliance activities.
• Prepare and maintain quality reports and records.

Skills

Quality Assurance experience

Regulated manufacturing environment

Analytical skills

Documentation skills

Cross-functional teamwork

Education

Bachelor's degree in Engineering, Life Sciences, or related technical field

Job description

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position

Quality Assurance Engineer

Location

Indiana

Duration

Long Term

Job Overview

We are seeking a Quality Assurance Engineer with strong experience in regulated manufacturing environments to support quality systems, compliance, documentation, and quality improvement activities.

Key Responsibilities

• Support quality assurance activities and maintain quality system documentation.
• Review and maintain quality records, procedures, and manufacturing documentation.
• Support deviations, CAPA, change controls, and root-cause investigations.
• Assist with internal and external quality audits.
• Work with Manufacturing, Engineering, Quality Control, and Regulatory teams to resolve quality issues.
• Ensure processes and documentation comply with GMP, FDA, and ISO requirements.
• Support continuous improvement and quality compliance activities.
• Prepare and maintain quality reports and records.

Required Qualifications

• Bachelor s degree in Engineering, Life Sciences, or a related technical field.
• 3+ years of experience in Quality Assurance within a pharmaceutical, medical device, biotech, or regulated manufacturing environment.
• Experience with GMP and quality systems.
• Knowledge of deviations, CAPA, change controls, and root-cause analysis.
• Experience With Quality Documentation And Compliance Requirements.
• Strong analytical, documentation, communication, and problem-solving skills.
• Ability to work effectively with cross-functional teams.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.