Pharma QA Engineer – Regulated Manufacturing & Compliance

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

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.