Quality Assurance Engineer
Actalent
About the role
Job Title
Quality Assurance Engineer
Job Description
The Quality Assurance Engineer is responsible for supporting the Quality organization in conducting investigations, change management, identifying and implementing continuous improvement opportunities, and maintaining GMP compliance.
Responsibilities
- Identify and implement corrective actions and investigate exceptions (deviations).
- Generate or review change controls for batch records, standard operating procedures, standard test methods, specifications, and data sheets.
- Employ 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.
- Ensure a safe and quality working environment through training, awareness, and compliance with safety and quality guidelines and SOPs.
- Maintain current knowledge of US and international quality regulations.
- Author or perform peer reviews of annual product quality reviews.
- Provide support for regulatory agency on‑site audits as required.
- Maintain operational compliance with US and international regulatory agencies and guidelines such as FDA, EU, HC, TGA, PIC/S, USP, NRC, and cGMP.
Essential Skills
- Bachelor of Science degree or equivalent work experience in lieu of a degree.
- 3‑7 of relevant experience in the pharmaceutical industry.
- Strong investigations experience.
Additional Skills & Qualifications
- Ability to resolve problems, handle conflict, and make effective decisions under pressure.
- Ability to perform simple to complex math calculations and analyze data.
- Hands‑on, analytical, and problem‑solving skills.
- High level of energy and consistent attendance.
Work Environment
This is an onsite position.
Job Type & Location
This is a Permanent position based out of Noblesville, IN.
Pay and Benefits
The pay range for this position is $72,000.00 – $77,000.00/yr.
- Medical Insurance
- Dental & Vision coverage
- 401(k) retirement Plan
- Paid time off and holidays
Workplace Type
This is a fully onsite position in Noblesville, IN.
Application Deadline
This position is anticipated to close on Mar 31, 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.
Requirements
- Bachelor of Science degree or equivalent work experience in lieu of a degree
- 3-7 of relevant experience in the pharmaceutical industry
- Strong investigations experience
- Additional Skills & Qualifications
- Ability to resolve problems, handle conflict, and make effective decisions under pressure
- Ability to perform simple to complex math calculations and analyze data
- Hands-on, analytical, and problem-solving skills
- High level of energy and consistent attendance
Responsibilities
- The Quality Assurance Engineer is responsible for supporting the Quality organization in conducting investigations, change management, identifying and implementing continuous improvement opportunities, and maintaining GMP compliance
- Identify and implement corrective actions and investigate exceptions (deviations)
- Generate or review change controls for batch records, standard operating procedures, standard test methods, specifications, and data sheets
- Employ 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
- Ensure a safe and quality working environment through training, awareness, and compliance with safety and quality guidelines and SOPs
- Maintain current knowledge of US and international quality regulations
- Author or perform peer reviews of annual product quality reviews
- Provide support for regulatory agency on-site audits as required
- Maintain operational compliance with US and international regulatory agencies and guidelines such as FDA, EU, HC, TGA, PIC/S, USP, NRC, and cGMP
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
Benefits
Skills
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