Quality Assurance Engineer

Job Title: Quality Assurance Engineer

Job Description

The Quality Assurance Engineer is responsible for supporting the Quality organization by conducting investigations, managing changes, identifying and implementing continuous improvement opportunities, and maintaining compliance with Good Manufacturing Practices (GMP).

Responsibilities

• Identify and implement corrective actions.
• Investigate exceptions and deviations.
• Generate or review change controls for batch records, standard operating procedures, standard test methods, specifications, and data sheets.
• Use quality tools such as FMEA, Fishbone, 5 Why, and Risk Analysis to support investigations and special projects.
• Perform data analysis to support investigations, cost savings, and continuous improvement initiatives.
• Work with radioactive materials while ensuring a safe and quality working environment.
• Maintain current knowledge of US and international quality regulations.
• Author or perform peer reviews of annual product quality reviews.
• Provide support during regulatory agency on-site audits, including those from the FDA, HC, TGA, and EU.
• Maintain operational compliance with US and international regulatory agencies and guidelines, including FDA, EU, HC, TGA, PIC/S, USP, NRC, and cGMP.

Essential Skills

• 3 or more years of relevant experience in the pharmaceutical industry.
• Strong investigations experience.
• Proficiency in quality assurance, investigation and analysis, SOP, audit, and document control.
• Experience in batch record review.

Additional Skills & Qualifications

• Bachelor of Science degree, or equivalent work experience.
• Ability to resolve problems, handle conflict, and make effective decisions under pressure.
• Ability to perform simple to complex math calculations, input data into a computer, and analyze data as required.
• Proficiency in Microsoft Office suite.
• Good computer skills, including the use of personal computers and data entry programs.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent writing and verbal communication skills.
• Ability to work independently and collaboratively to accomplish goals and priorities.
• High level of energy and consistent attendance.

This is a Permanent position based out of Indianapolis, IN.

The pay range for this position is $72000.00 - $77000.00/yr.

- medical Insurance- Dental & Vision coverage- 401 (k) retirment Plan- Paid time off and holidays

This is a fully onsite position in Indianapolis,IN.

This position is anticipated to close on Apr 7, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.